[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DEH":3},{"classification":4,"mappedDevices":108,"similarCandidates":109,"relatedClassifications":181,"syncDates":230},{"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":101,"updated_at":102,"recall_count":103,"latest_recall_date":104,"k510_count":105,"pma_count":106,"event_count":107},4071,"DEH","Lambda, Antigen, Antiserum, Control","2","866.5550","IM","Immunology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":98,"product_code":6,"review_panel":10,"gmp_exempt_flag":98,"third_party_flag":99,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":98,"medical_specialty_description":11,"summary_malfunction_reporting":100},{"k_number":17,"fei_number":71,"registration_number":90},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70],"K940331","K940583","K791115","K950148","K924726","K941604","K010441","K931192","K941782","K941514","K842328","K896918","K940424","K023131","K950149","K771768","K140396","K010440","K002563","K936111","K941516","K832261","K832270","K855007","K941505","K941170","K033811","K971905","K950151","K083601","K003671","K965022","K852999","K941784","K841864","K951965","K781025","K973393","K924804","K941397","K902485","K935161","K875165","K781220","K031016","K932326","K172471","K812662","K855013","K932136","K941707","K791283","K941173",[72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89],"2050010","6387","3003423869","2083566","3002806778","3012471076","3013059683","3014271897","3002808340","3001236277","3009189893","3019906","2050012","3001644026","3003961883","3000303338","3004445302","1618982",[91,72,74,75,92,77,93,94,79,78,83,95,82,84,96,86,89,97],"2032900","8023024","9610806","9610099","9681753","9614373","1649518","N","Y","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",4,"2021-12-01",53,0,78,[],[110,118,126,134,141,147,154,161,168,174],{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":106,"vector_similarity":116,"score":117},3277,"X線自動露出制御器","Ⅰ","34311000",0.169811,0.590035,0.0312576,{"medical_device_id":119,"generic_name":120,"class_classification":121,"jmdn_code":122,"name_similarity":123,"definition_similarity":106,"vector_similarity":124,"score":125},2480,"天蓋加温装置コントロールユニット","Ⅱ","36953000",0.166667,0.576189,0.0296313,{"medical_device_id":127,"generic_name":128,"class_classification":129,"jmdn_code":130,"name_similarity":131,"definition_similarity":106,"vector_similarity":132,"score":133},692,"透析用監視装置","Ⅲ","36424000",0.142857,0.582638,0.0271997,{"medical_device_id":135,"generic_name":136,"class_classification":129,"jmdn_code":137,"name_similarity":138,"definition_similarity":106,"vector_similarity":139,"score":140},1125,"植込み能動型機器管理用プログラム","71052003",0.15625,0.562928,0.026084,{"medical_device_id":142,"generic_name":143,"class_classification":121,"jmdn_code":144,"name_similarity":131,"definition_similarity":106,"vector_similarity":145,"score":146},2248,"局所管理生理食塩液含有創傷被覆・保護材","37298002",0.572988,0.0256536,{"medical_device_id":148,"generic_name":149,"class_classification":121,"jmdn_code":150,"name_similarity":151,"definition_similarity":106,"vector_similarity":152,"score":153},2487,"ウォーターパッド加温装置コントロールユニット","36956010",0.153846,0.56202,0.0256034,{"medical_device_id":155,"generic_name":156,"class_classification":121,"jmdn_code":157,"name_similarity":158,"definition_similarity":106,"vector_similarity":159,"score":160},2174,"輸液セット用コントローラ","36244000",0.137931,0.55916,0.0223471,{"medical_device_id":162,"generic_name":163,"class_classification":121,"jmdn_code":164,"name_similarity":165,"definition_similarity":106,"vector_similarity":166,"score":167},2446,"酸素コントローラ","70577000",0.236842,0.526888,0.0163934,{"medical_device_id":169,"generic_name":170,"class_classification":113,"jmdn_code":171,"name_similarity":172,"definition_similarity":106,"vector_similarity":173,"score":167},3514,"粒子計測免疫測定装置","70181000",0.0967742,0.613728,{"medical_device_id":175,"generic_name":176,"class_classification":129,"jmdn_code":177,"name_similarity":178,"definition_similarity":106,"vector_similarity":179,"score":180},886,"モータ付自動絞り加速装置用コリメータ","38138000",0.115385,0.600635,0.016129,[182,186,190,194,198,201,204,208,211,214,218,221,224,227],{"product_code":183,"device_name":184,"device_class":8,"k510_count":185},"DFH","Kappa, Antigen, Antiserum, Control",63,{"product_code":187,"device_name":188,"device_class":8,"k510_count":189},"DFT","Igm, Antigen, Antiserum, Control",33,{"product_code":191,"device_name":192,"device_class":8,"k510_count":193},"DAO","Igm (Mu Chain Specific), Antigen, Antiserum, Control",8,{"product_code":195,"device_name":196,"device_class":8,"k510_count":197},"DEY","Igm, Peroxidase, Antigen, Antiserum, Control",3,{"product_code":199,"device_name":200,"device_class":8,"k510_count":197},"DFD","Kappa, Peroxidase, Antigen, Antiserum, Control",{"product_code":202,"device_name":203,"device_class":8,"k510_count":197},"DFL","Igm, Ferritin, Antigen, Antiserum, Control",{"product_code":205,"device_name":206,"device_class":8,"k510_count":207},"DEO","Kappa, Fitc, Antigen, Antiserum, Control",2,{"product_code":209,"device_name":210,"device_class":8,"k510_count":207},"DES","Lambda, Fitc, Antigen, Antiserum, Control",{"product_code":212,"device_name":213,"device_class":8,"k510_count":207},"LYE","Cytokeratins",{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"DEP","Lambda, Peroxidase, Antigen, Antiserum, Control",1,{"product_code":219,"device_name":220,"device_class":8,"k510_count":217},"DFG","Lambda, Rhodamine, Antigen, Antiserum, Control",{"product_code":222,"device_name":223,"device_class":8,"k510_count":217},"DFS","Igm, Fitc, Antigen, Antiserum, Control",{"product_code":225,"device_name":226,"device_class":8,"k510_count":106},"DEK","Kappa, Rhodamine, Antigen, Antiserum, Control",{"product_code":228,"device_name":229,"device_class":8,"k510_count":106},"DEZ","Igm, Rhodamine, Antigen, Antiserum, Control",{"510k":231,"classification":232,"enforcement":233,"event":234,"pma":235,"warning_letter":236},"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"]