[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DGO":3},{"classification":4,"mappedDevices":47,"similarCandidates":48,"relatedClassifications":119,"syncDates":239},{"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":42,"updated_at":43,"recall_count":44,"latest_recall_date":45,"k510_count":46,"pma_count":44,"event_count":44},1243,"DGO","Ige, 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":39,"product_code":6,"review_panel":12,"gmp_exempt_flag":39,"third_party_flag":40,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":39,"medical_specialty_description":11,"summary_malfunction_reporting":41},{"k_number":18,"fei_number":34,"registration_number":38},[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"K831987","K894039","K920087","K893125","K821094","K831984","K831774","K830495","K853607","K860851","K830653","K911511","K943194","K872801","K800995",[35,36,37],"3002806944","1036362","3006198300",[35,36,37],"N","Y","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",0,null,15,[],[49,57,65,73,80,86,93,100,106,113],{"medical_device_id":50,"generic_name":51,"class_classification":52,"jmdn_code":53,"name_similarity":54,"definition_similarity":44,"vector_similarity":55,"score":56},456,"注射筒輸液ポンプコントロールユニット","Ⅲ","37217000",0.183333,0.540997,0.029116,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":44,"vector_similarity":63,"score":64},3277,"X線自動露出制御器","Ⅰ","34311000",0.15,0.55148,0.0283702,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":44,"vector_similarity":71,"score":72},2174,"輸液セット用コントローラ","Ⅱ","36244000",0.140625,0.538864,0.0248457,{"medical_device_id":74,"generic_name":75,"class_classification":68,"jmdn_code":76,"name_similarity":77,"definition_similarity":44,"vector_similarity":78,"score":79},2446,"酸素コントローラ","70577000",0.2,0.524902,0.0163934,{"medical_device_id":81,"generic_name":82,"class_classification":60,"jmdn_code":83,"name_similarity":84,"definition_similarity":44,"vector_similarity":85,"score":79},3514,"粒子計測免疫測定装置","70181000",0.119403,0.599279,{"medical_device_id":87,"generic_name":88,"class_classification":60,"jmdn_code":89,"name_similarity":90,"definition_similarity":44,"vector_similarity":91,"score":92},3506,"移動式酵素免疫測定装置","35706020",0.0597015,0.590017,0.016129,{"medical_device_id":94,"generic_name":95,"class_classification":68,"jmdn_code":96,"name_similarity":97,"definition_similarity":44,"vector_similarity":98,"score":99},2500,"エアパッド加温装置コントロールユニット","36954010",0.181818,0.500077,0.015873,{"medical_device_id":101,"generic_name":102,"class_classification":60,"jmdn_code":103,"name_similarity":104,"definition_similarity":44,"vector_similarity":105,"score":99},3510,"免疫蛍光分析装置","35707010",0.0677966,0.587292,{"medical_device_id":107,"generic_name":108,"class_classification":60,"jmdn_code":109,"name_similarity":110,"definition_similarity":44,"vector_similarity":111,"score":112},3505,"酵素免疫測定装置","35706010",0.0666667,0.584537,0.015625,{"medical_device_id":114,"generic_name":115,"class_classification":60,"jmdn_code":116,"name_similarity":117,"definition_similarity":44,"vector_similarity":118,"score":112},3589,"低温温度制御装置","16538000",0.166667,0.509835,[120,124,128,132,136,140,144,148,151,155,159,162,166,170,173,176,180,183,186,190,193,196,200,203,206,209,212,215,218,221,224,227,230,233,236],{"product_code":121,"device_name":122,"device_class":8,"k510_count":123},"DGC","Ige, Antigen, Antiserum, Control",114,{"product_code":125,"device_name":126,"device_class":8,"k510_count":127},"DEW","Igg, Antigen, Antiserum, Control",76,{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"CFN","Method, Nephelometric, Immunoglobulins (G, A, M)",61,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"CZP","Iga, Antigen, Antiserum, Control",54,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"CFF","Immunoelectrophoretic, Immunoglobulins, (G, A, M)",29,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"CFQ","Radioimmunoassay, Immunoglobulins (G, A, M)",12,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"DFZ","Igg (Gamma Chain Specific), Antigen, Antiserum, Control",9,{"product_code":149,"device_name":150,"device_class":8,"k510_count":147},"JHR","Radioimmunoassay, Immunoglobulins (D, E)",{"product_code":152,"device_name":153,"device_class":8,"k510_count":154},"CZJ","Igd, Antigen, Antiserum, Control",8,{"product_code":156,"device_name":157,"device_class":8,"k510_count":158},"CZN","Iga, Fitc, Antigen, Antiserum, Control",7,{"product_code":160,"device_name":161,"device_class":8,"k510_count":158},"DAH","Gamma Globulin, Antigen, Antiserum, Control",{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"DAA","Igg, Peroxidase, Antigen, Antiserum, Control",5,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"CGM","Method, Immunodiffusion, Immunoglobulins (G, A, M)",4,{"product_code":171,"device_name":172,"device_class":8,"k510_count":169},"DGP","Ige, Fitc, Antigen, Antiserum, Control",{"product_code":174,"device_name":175,"device_class":8,"k510_count":169},"KTS","Second Antibody (Species Specific Anti-Animal Gamma Globulin)",{"product_code":177,"device_name":178,"device_class":8,"k510_count":179},"DGD","Igg, Ferritin, Antigen, Antiserum, Control",3,{"product_code":181,"device_name":182,"device_class":8,"k510_count":179},"OPX","Immunoglobulin A Kappa Heavy & Light Chain Combined",{"product_code":184,"device_name":185,"device_class":8,"k510_count":179},"PCN","Immunoglobulin G Kappa Heavy And Light Chain Combined",{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"DGE","Igd, Rhodamine, Antigen, Antiserum, Control",2,{"product_code":191,"device_name":192,"device_class":8,"k510_count":189},"DGK","Igg, Fitc, Antigen, Antiserum, Control",{"product_code":194,"device_name":195,"device_class":8,"k510_count":189},"PDE","Immunoglobulin M Kappa Heavy And Light Chain Combined",{"product_code":197,"device_name":198,"device_class":8,"k510_count":199},"CZK","Iga, Rhodamine, Antigen, Antiserum, Control",1,{"product_code":201,"device_name":202,"device_class":8,"k510_count":199},"CZM","Iga, Ferritin, Antigen, Antiserum, Control",{"product_code":204,"device_name":205,"device_class":8,"k510_count":199},"DAF","Gamma Globulin, Fitc, Antigen, Antiserum, Control",{"product_code":207,"device_name":208,"device_class":8,"k510_count":199},"DGH","Igd, Peroxidase, Antigen, Antiserum, Control",{"product_code":210,"device_name":211,"device_class":8,"k510_count":199},"SGG","Mass Spectrometric, Immunoglobulins (G, A, M, D, E)",{"product_code":213,"device_name":214,"device_class":8,"k510_count":44},"CZL","Iga, Peroxidase, Antigen, Antiserum, Control",{"product_code":216,"device_name":217,"device_class":8,"k510_count":44},"DFM","Ige, Ferritin, Antigen, Antiserum, Control",{"product_code":219,"device_name":220,"device_class":8,"k510_count":44},"DFO","Igg, Rhodamine, Antigen, Antiserum, Control",{"product_code":222,"device_name":223,"device_class":8,"k510_count":44},"DGG","Igd, Fitc, Antigen, Antiserum, Control",{"product_code":225,"device_name":226,"device_class":8,"k510_count":44},"DGL","Ige, Rhodamine, Antigen, Antiserum, Control",{"product_code":228,"device_name":229,"device_class":8,"k510_count":44},"MLH","Strip, Hama Igg, Elisa, In Vitro Test System",{"product_code":231,"device_name":232,"device_class":8,"k510_count":44},"OPY","Igal Heavy & Light Chain Combined",{"product_code":234,"device_name":235,"device_class":8,"k510_count":44},"PCO","Immunoglobulin G Lambda Heavy And Light Chain Combined",{"product_code":237,"device_name":238,"device_class":8,"k510_count":44},"PDF","Immunoglobulin M Lambda Heavy And Light Chain Combined",{"510k":240,"classification":241,"enforcement":242,"event":243,"pma":244,"warning_letter":245},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]