[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DGH":3},{"classification":4,"mappedDevices":28,"similarCandidates":29,"relatedClassifications":101,"syncDates":221,"translation":228,"marketSummary":234,"recalls":247,"k510s":249,"pmas":256},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":23,"updated_at":24,"recall_count":25,"latest_recall_date":26,"k510_count":27,"pma_count":25,"event_count":25},6892,"DGH","Igd, Peroxidase, Antigen, Antiserum, Control","2","866.5510","IM","Immunology","PA","1","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":20,"product_code":6,"review_panel":12,"gmp_exempt_flag":20,"third_party_flag":21,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":20,"medical_specialty_description":11,"summary_malfunction_reporting":22},{"k_number":18},[19],"K812076","N","Y","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:47.808424+00:00",0,null,1,[],[30,38,46,54,61,68,75,81,88,94],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":25,"vector_similarity":36,"score":37},3277,"X線自動露出制御器","Ⅰ","34311000",0.147541,0.57705,0.0281746,{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":25,"vector_similarity":44,"score":45},2446,"酸素コントローラ","Ⅱ","70577000",0.195652,0.553202,0.0276294,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":25,"vector_similarity":52,"score":53},456,"注射筒輸液ポンプコントロールユニット","Ⅲ","37217000",0.16129,0.56409,0.0274328,{"medical_device_id":55,"generic_name":56,"class_classification":41,"jmdn_code":57,"name_similarity":58,"definition_similarity":25,"vector_similarity":59,"score":60},2174,"輸液セット用コントローラ","36244000",0.138462,0.572144,0.0253205,{"medical_device_id":62,"generic_name":63,"class_classification":33,"jmdn_code":64,"name_similarity":65,"definition_similarity":25,"vector_similarity":66,"score":67},3510,"免疫蛍光分析装置","35707010",0.0666667,0.625271,0.0163934,{"medical_device_id":69,"generic_name":70,"class_classification":41,"jmdn_code":71,"name_similarity":72,"definition_similarity":25,"vector_similarity":73,"score":74},2500,"エアパッド加温装置コントロールユニット","36954010",0.178571,0.490767,0.016129,{"medical_device_id":76,"generic_name":77,"class_classification":33,"jmdn_code":78,"name_similarity":79,"definition_similarity":25,"vector_similarity":80,"score":74},3506,"移動式酵素免疫測定装置","35706020",0.0588235,0.623273,{"medical_device_id":82,"generic_name":83,"class_classification":33,"jmdn_code":84,"name_similarity":85,"definition_similarity":25,"vector_similarity":86,"score":87},3511,"移動式免疫蛍光分析装置","35707020",0.0597015,0.620169,0.015873,{"medical_device_id":89,"generic_name":90,"class_classification":33,"jmdn_code":91,"name_similarity":92,"definition_similarity":25,"vector_similarity":93,"score":87},3589,"低温温度制御装置","16538000",0.163934,0.544388,{"medical_device_id":95,"generic_name":96,"class_classification":49,"jmdn_code":97,"name_similarity":98,"definition_similarity":25,"vector_similarity":99,"score":100},454,"患者管理無痛法用輸液ポンプ","35932000",0.161765,0.519898,0.015625,[102,106,110,114,118,122,126,130,134,137,141,145,148,152,156,159,162,166,169,172,176,179,182,185,188,191,194,197,200,203,206,209,212,215,218],{"product_code":103,"device_name":104,"device_class":8,"k510_count":105},"DGC","Ige, Antigen, Antiserum, Control",114,{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"DEW","Igg, Antigen, Antiserum, Control",76,{"product_code":111,"device_name":112,"device_class":8,"k510_count":113},"CFN","Method, Nephelometric, Immunoglobulins (G, A, M)",61,{"product_code":115,"device_name":116,"device_class":8,"k510_count":117},"CZP","Iga, Antigen, Antiserum, Control",54,{"product_code":119,"device_name":120,"device_class":8,"k510_count":121},"CFF","Immunoelectrophoretic, Immunoglobulins, (G, A, M)",29,{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"DGO","Ige, Peroxidase, Antigen, Antiserum, Control",15,{"product_code":127,"device_name":128,"device_class":8,"k510_count":129},"CFQ","Radioimmunoassay, Immunoglobulins (G, A, M)",12,{"product_code":131,"device_name":132,"device_class":8,"k510_count":133},"DFZ","Igg (Gamma Chain Specific), Antigen, Antiserum, Control",9,{"product_code":135,"device_name":136,"device_class":8,"k510_count":133},"JHR","Radioimmunoassay, Immunoglobulins (D, E)",{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"CZJ","Igd, Antigen, Antiserum, Control",8,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"CZN","Iga, Fitc, Antigen, Antiserum, Control",7,{"product_code":146,"device_name":147,"device_class":8,"k510_count":144},"DAH","Gamma Globulin, Antigen, Antiserum, Control",{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"DAA","Igg, Peroxidase, Antigen, Antiserum, Control",5,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"CGM","Method, Immunodiffusion, Immunoglobulins (G, A, M)",4,{"product_code":157,"device_name":158,"device_class":8,"k510_count":155},"DGP","Ige, Fitc, Antigen, Antiserum, Control",{"product_code":160,"device_name":161,"device_class":8,"k510_count":155},"KTS","Second Antibody (Species Specific Anti-Animal Gamma Globulin)",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"DGD","Igg, Ferritin, Antigen, Antiserum, Control",3,{"product_code":167,"device_name":168,"device_class":8,"k510_count":165},"OPX","Immunoglobulin A Kappa Heavy & Light Chain Combined",{"product_code":170,"device_name":171,"device_class":8,"k510_count":165},"PCN","Immunoglobulin G Kappa Heavy And Light Chain Combined",{"product_code":173,"device_name":174,"device_class":8,"k510_count":175},"DGE","Igd, Rhodamine, Antigen, Antiserum, Control",2,{"product_code":177,"device_name":178,"device_class":8,"k510_count":175},"DGK","Igg, Fitc, Antigen, Antiserum, Control",{"product_code":180,"device_name":181,"device_class":8,"k510_count":175},"PDE","Immunoglobulin M Kappa Heavy And Light Chain Combined",{"product_code":183,"device_name":184,"device_class":8,"k510_count":27},"CZK","Iga, Rhodamine, Antigen, Antiserum, Control",{"product_code":186,"device_name":187,"device_class":8,"k510_count":27},"CZM","Iga, Ferritin, Antigen, Antiserum, Control",{"product_code":189,"device_name":190,"device_class":8,"k510_count":27},"DAF","Gamma Globulin, Fitc, Antigen, Antiserum, Control",{"product_code":192,"device_name":193,"device_class":8,"k510_count":27},"SGG","Mass Spectrometric, Immunoglobulins (G, A, M, D, E)",{"product_code":195,"device_name":196,"device_class":8,"k510_count":25},"CZL","Iga, Peroxidase, Antigen, Antiserum, Control",{"product_code":198,"device_name":199,"device_class":8,"k510_count":25},"DFM","Ige, Ferritin, Antigen, Antiserum, Control",{"product_code":201,"device_name":202,"device_class":8,"k510_count":25},"DFO","Igg, Rhodamine, Antigen, Antiserum, Control",{"product_code":204,"device_name":205,"device_class":8,"k510_count":25},"DGG","Igd, Fitc, Antigen, Antiserum, Control",{"product_code":207,"device_name":208,"device_class":8,"k510_count":25},"DGL","Ige, Rhodamine, Antigen, Antiserum, Control",{"product_code":210,"device_name":211,"device_class":8,"k510_count":25},"MLH","Strip, Hama Igg, Elisa, In Vitro Test System",{"product_code":213,"device_name":214,"device_class":8,"k510_count":25},"OPY","Igal Heavy & Light Chain Combined",{"product_code":216,"device_name":217,"device_class":8,"k510_count":25},"PCO","Immunoglobulin G Lambda Heavy And Light Chain Combined",{"product_code":219,"device_name":220,"device_class":8,"k510_count":25},"PDF","Immunoglobulin M Lambda Heavy And Light Chain Combined",{"510k":222,"classification":223,"enforcement":224,"event":225,"pma":226,"warning_letter":227},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":229,"definition_ja":26,"commentary_ja":230,"model_name":231,"source_hash":232,"reviewed_by":26,"reviewed_at":26,"created_at":233,"updated_at":233},"免疫グロブリンD（IgD）ペルオキシダーゼ抗原抗血清コントロール","本品は、免疫グロブリンD（IgD）を検出・定量する免疫化学的検査システムにおいて、ペルオキシダーゼ標識抗原および抗血清の反応性を確認するために用いられる対照品（コントロール）です。米国ではクラスIIに分類され、市販前届出（510(k)）による審査を経て市販が認められる区分に該当します。","claude-sonnet-5","279d7a20214467dc24529f967ac05f2b5fb4918c39324b75a3a8eb4dcd22111b","2026-08-24T01:46:26.815929+00:00",{"product_code":6,"summary_ja":235,"stats":236,"stats_hash":245,"model_name":231,"created_at":246,"updated_at":246},"本製品コードにおける510(k)の累計件数は1件で、参入企業数は1社にとどまり、直近5年間の届出は確認されていません。不具合報告（MDR）については累計報告件数が0件であり、報告事例は確認されていません。回収についても累計件数は0件で、クラスI・II・IIIいずれの記録も確認されていません。",{"pma":237,"k510":238,"as_of":240,"events":241,"recalls":242,"top_problems":244},{"latest":26,"originals":25,"supplements":25},{"total":27,"last5y":25,"latest":239,"applicants":27},"1981-08-12","2026-08",{"death":25,"other":25,"total":25,"injury":25,"last5y":25,"malfunction":25,"latest_month":26},{"total":25,"last5y":25,"latest":26,"class_i":25,"class_ii":25,"class_iii":25,"top_root_causes":243},[],[],"29f7c2ad6e3638d2d7cb111e1f84964837f63b49ecf4634b27324530e254ce68","2026-08-24T04:11:59.548648+00:00",{"items":248,"total":25},[],{"items":250,"total":27},[251],{"k_number":19,"device_name":252,"applicant":253,"decision_date":239,"clearance_type":254,"decision_code":255,"statement_or_summary":26},"ANTI-GM & ANTI-KM TYPING SERUMS","Biotest-Serum-Institut","Traditional","SESE",{"items":257,"total":25},[]]