[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DEX":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":107,"syncDates":116,"translation":123,"marketSummary":129,"recalls":143,"k510s":145,"pmas":168},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":32,"pma_count":30,"event_count":33},1215,"DEX","Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control","1","866.5420","IM","Immunology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":10,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":26,"medical_specialty_description":11,"summary_malfunction_reporting":27},{"k_number":17,"fei_number":23,"registration_number":25},[18,19,20,21,22],"K801909","K791341","K823765","K760143","K781023",[24],"3019906",[24],"N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.949024+00:00",0,null,5,3,[],[36,44,51,59,65,73,80,88,94,101],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":30,"vector_similarity":42,"score":43},3523,"グリコヘモグロビン分析装置","Ⅰ","35968000",0.15,0.596739,0.032002,{"medical_device_id":45,"generic_name":46,"class_classification":39,"jmdn_code":47,"name_similarity":48,"definition_similarity":30,"vector_similarity":49,"score":50},3277,"X線自動露出制御器","34311000",0.132353,0.563298,0.0268301,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":56,"definition_similarity":30,"vector_similarity":57,"score":58},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.0810811,0.604467,0.0163934,{"medical_device_id":60,"generic_name":61,"class_classification":39,"jmdn_code":62,"name_similarity":63,"definition_similarity":30,"vector_similarity":64,"score":58},3504,"蛋白質分析装置","30857000",0.173077,0.538655,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":30,"vector_similarity":71,"score":72},2446,"酸素コントローラ","Ⅱ","70577000",0.169811,0.500696,0.016129,{"medical_device_id":74,"generic_name":75,"class_classification":39,"jmdn_code":76,"name_similarity":77,"definition_similarity":30,"vector_similarity":78,"score":79},3514,"粒子計測免疫測定装置","70181000",0.0779221,0.592353,0.015873,{"medical_device_id":81,"generic_name":82,"class_classification":83,"jmdn_code":84,"name_similarity":85,"definition_similarity":30,"vector_similarity":86,"score":87},718,"人工心肺用ガスコントロールユニット","Ⅲ","31714000",0.144928,0.526565,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":39,"jmdn_code":91,"name_similarity":92,"definition_similarity":30,"vector_similarity":93,"score":87},3511,"移動式免疫蛍光分析装置","35707020",0.04,0.579604,{"medical_device_id":95,"generic_name":96,"class_classification":68,"jmdn_code":97,"name_similarity":98,"definition_similarity":30,"vector_similarity":99,"score":100},2500,"エアパッド加温装置コントロールユニット","36954010",0.140625,0.479001,0.0153846,{"medical_device_id":102,"generic_name":103,"class_classification":39,"jmdn_code":104,"name_similarity":105,"definition_similarity":30,"vector_similarity":106,"score":100},3510,"免疫蛍光分析装置","35707010",0.0441176,0.57465,[108,112],{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"LKL","Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control",11,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"DEN","Alpha-1-T-Glycoprotein, Antigen, Antiserum, Control",2,{"510k":117,"classification":118,"enforcement":119,"event":120,"pma":121,"warning_letter":122},"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":124,"definition_ja":31,"commentary_ja":125,"model_name":126,"source_hash":127,"reviewed_by":31,"reviewed_at":31,"created_at":128,"updated_at":128},"アルファ1-Bグリコプロテイン抗原・抗血清・コントロール","本品は米国FDAの分類においてクラスIに該当する医療機器です。クラスIは一般的に人体へのリスクが低いとされる機器区分であり、本品は510(k)による市販前届出が免除されている製品です。","claude-sonnet-5","42777bcbb05e7bf57579069738e73b8773531b63f4e133188a67511f2477656a","2026-08-24T01:46:26.815929+00:00",{"product_code":6,"summary_ja":130,"stats":131,"stats_hash":141,"model_name":126,"created_at":142,"updated_at":142},"本製品コードの510(k)は累計5件で、参入企業数は5社となっていますが、直近5年間の届出実績はなく、最新の判定は1982年12月です。不具合報告は累計3件で、いずれもMalfunction（不具合）として報告されており、死亡・傷害の報告は確認されていません。直近5年間の報告はなく、最新の報告月は2011年11月です。回収については累計0件で、クラスI・II・IIIのいずれも報告されていません。",{"pma":132,"k510":133,"as_of":135,"events":136,"recalls":138,"top_problems":140},{"latest":31,"originals":30,"supplements":30},{"total":32,"last5y":30,"latest":134,"applicants":32},"1982-12-30","2026-08",{"death":30,"other":30,"total":33,"injury":30,"last5y":30,"malfunction":33,"latest_month":137},"2011-11",{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":139},[],[],"8404fdf882f30cc422f93b5d358a7f637e99fdb131f0757b83d79fffcae37bd1","2026-08-24T04:11:59.548648+00:00",{"items":144,"total":30},[],{"items":146,"total":32},[147,152,156,160,164],{"k_number":20,"device_name":148,"applicant":149,"decision_date":134,"clearance_type":150,"decision_code":151,"statement_or_summary":31},"ANTI SERA TO HUMAN OROSCOMUCOID","Kent Laboratories, Inc.","Traditional","SESE",{"k_number":18,"device_name":153,"applicant":154,"decision_date":155,"clearance_type":150,"decision_code":151,"statement_or_summary":31},"LSA 290 ASSAY REAGENTS\u002FNEPHELOMETRIC","J.T. Baker Chemical Co.","1980-09-26",{"k_number":19,"device_name":157,"applicant":158,"decision_date":159,"clearance_type":150,"decision_code":151,"statement_or_summary":31},"HUMAN ALPHA, ACID GLYCOPROTEIN","Beckman Instruments, Inc.","1979-08-16",{"k_number":22,"device_name":161,"applicant":162,"decision_date":163,"clearance_type":150,"decision_code":151,"statement_or_summary":31},"ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU","Icl Scientific","1978-08-14",{"k_number":21,"device_name":165,"applicant":166,"decision_date":167,"clearance_type":150,"decision_code":151,"statement_or_summary":31},"SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN","Oxford Laboratories, Inc.","1976-07-20",{"items":169,"total":30},[]]