[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CHI":3},{"classification":4,"mappedDevices":87,"similarCandidates":88,"relatedClassifications":158,"syncDates":167},{"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":80,"updated_at":81,"recall_count":82,"latest_recall_date":83,"k510_count":84,"pma_count":85,"event_count":86},1321,"CHI","Lipase-Esterase, Enzymatic, Photometric, Lipase","1","862.1465","CH","Clinical Chemistry","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":78,"product_code":6,"review_panel":10,"gmp_exempt_flag":78,"third_party_flag":78,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":78,"medical_specialty_description":11,"summary_malfunction_reporting":79},{"k_number":17,"fei_number":38,"registration_number":68},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"K884596","K970905","K961179","K874640","K923917","K941085","K900827","K874027","K811553","K952647","K952816","K802842","K875173","K845027","K897150","K920337","K862312","K952180","K760786","K921249",[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],"1220972","1827821","3006769061","1000122044","3000303338","3003741796","3002809144","3002806809","3016438761","2432235","3005094123","3021841051","3010825766","2050012","2050010","3013660430","5864","2250051","3005333358","1000305840","3004445302","3007662974","3004493545","1000136573","3000148879","2517506","3012240236","3002806559","3014325803",[39,40,69,70,44,45,47,48,49,50,51,52,71,72,53,54,73,74,75,56,57,76,60,77,61,63,64,65,67],"1319809","3003539867","2032900","9610126","2247288","1319681","9681753","8020316","8040374","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-18T22:05:38.961415+00:00",22,"2023-11-15",20,0,93,[],[89,97,104,111,118,125,131,138,145,151],{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":85,"vector_similarity":95,"score":96},3494,"汎用分光光度分析装置","Ⅰ","36910000",0.2,0.6338,0.0327869,{"medical_device_id":98,"generic_name":99,"class_classification":92,"jmdn_code":100,"name_similarity":101,"definition_similarity":85,"vector_similarity":102,"score":103},3496,"炎光式電解質分析装置","35826000",0.163934,0.585754,0.0307984,{"medical_device_id":105,"generic_name":106,"class_classification":92,"jmdn_code":107,"name_similarity":108,"definition_similarity":85,"vector_similarity":109,"score":110},3575,"比ろう法比濁分析装置","15163000",0.117647,0.583287,0.02578,{"medical_device_id":112,"generic_name":113,"class_classification":92,"jmdn_code":114,"name_similarity":115,"definition_similarity":85,"vector_similarity":116,"score":117},3500,"クーロメトリー式電解質分析装置","35903000",0.116667,0.578056,0.0247495,{"medical_device_id":119,"generic_name":120,"class_classification":92,"jmdn_code":121,"name_similarity":122,"definition_similarity":85,"vector_similarity":123,"score":124},3384,"自動視野計","16918001",0.173913,0.515108,0.016129,{"medical_device_id":126,"generic_name":127,"class_classification":92,"jmdn_code":128,"name_similarity":129,"definition_similarity":85,"vector_similarity":130,"score":124},3535,"酵素分析装置","35470000",0.111111,0.627591,{"medical_device_id":132,"generic_name":133,"class_classification":92,"jmdn_code":134,"name_similarity":135,"definition_similarity":85,"vector_similarity":136,"score":137},3517,"ラクテート分析装置","35885000",0.02,0.608633,0.015873,{"medical_device_id":139,"generic_name":140,"class_classification":92,"jmdn_code":141,"name_similarity":142,"definition_similarity":85,"vector_similarity":143,"score":144},3408,"眼位計","17119000",0.153846,0.518526,0.015625,{"medical_device_id":146,"generic_name":147,"class_classification":92,"jmdn_code":148,"name_similarity":149,"definition_similarity":85,"vector_similarity":150,"score":144},3506,"移動式酵素免疫測定装置","35706020",0.078125,0.60678,{"medical_device_id":152,"generic_name":153,"class_classification":154,"jmdn_code":155,"name_similarity":142,"definition_similarity":85,"vector_similarity":156,"score":157},917,"眼科用レーザ光凝固装置","Ⅲ","70634000",0.543796,0.0153846,[159,163],{"product_code":160,"device_name":161,"device_class":8,"k510_count":162},"CET","Olive Oil Emulsion (Turbidimetric), Lipase",15,{"product_code":164,"device_name":165,"device_class":8,"k510_count":166},"CFG","Oil Emulsion\u002FThymolphthalein (Titrimetric), Lipase",2,{"510k":168,"classification":169,"enforcement":170,"event":171,"pma":172,"warning_letter":173},"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"]