[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LCH":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":110,"syncDates":156},{"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":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":39,"event_count":39},1941,"LCH","Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical","1","862.1660","CH","Clinical Chemistry","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":32,"product_code":6,"review_panel":10,"gmp_exempt_flag":32,"third_party_flag":32,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":32,"medical_specialty_description":11,"summary_malfunction_reporting":33},{"k_number":17,"fei_number":27,"registration_number":31},[18,19,20,21,22,23,24,25,26],"K801599","K781386","K900819","K781417","K862958","K841089","K802379","K904163","K922386",[28,29,30],"3011898560","3013846070","3020756",[28,29,30],"N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",2,null,9,0,[],[42,50,57,63,70,77,84,90,97,103],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":39,"vector_similarity":48,"score":49},3528,"血液ガス酸素分析装置","Ⅰ","12590000",0.191781,0.69148,0.0283716,{"medical_device_id":51,"generic_name":52,"class_classification":45,"jmdn_code":53,"name_similarity":54,"definition_similarity":39,"vector_similarity":55,"score":56},3529,"汎用血液ガス分析装置","30847000",0.17284,0.69413,0.0261717,{"medical_device_id":58,"generic_name":59,"class_classification":45,"jmdn_code":60,"name_similarity":54,"definition_similarity":39,"vector_similarity":61,"score":62},3531,"体外型血液ガス分析装置","37238000",0.694957,0.0260443,{"medical_device_id":64,"generic_name":65,"class_classification":45,"jmdn_code":66,"name_similarity":67,"definition_similarity":39,"vector_similarity":68,"score":69},3732,"ダイヤル目盛付輸液用ラインクランプ","35894000",0.185185,0.677642,0.0256039,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":54,"definition_similarity":39,"vector_similarity":75,"score":76},1532,"経皮血中ガス分析装置","Ⅱ","36346000",0.687225,0.0248457,{"medical_device_id":78,"generic_name":79,"class_classification":73,"jmdn_code":80,"name_similarity":81,"definition_similarity":39,"vector_similarity":82,"score":83},1415,"眼圧計","16809000",0.15493,0.767183,0.0163934,{"medical_device_id":85,"generic_name":86,"class_classification":45,"jmdn_code":87,"name_similarity":88,"definition_similarity":39,"vector_similarity":89,"score":83},3640,"採血用穿刺器具","70226000",0.209877,0.648377,{"medical_device_id":91,"generic_name":92,"class_classification":73,"jmdn_code":93,"name_similarity":94,"definition_similarity":39,"vector_similarity":95,"score":96},1595,"レフラクト・ケラト・トノメータ","36387060",0.146667,0.753303,0.016129,{"medical_device_id":98,"generic_name":99,"class_classification":73,"jmdn_code":100,"name_similarity":101,"definition_similarity":39,"vector_similarity":102,"score":96},2538,"卵管疎通診断処置用器具","70616000",0.194444,0.583737,{"medical_device_id":104,"generic_name":105,"class_classification":73,"jmdn_code":106,"name_similarity":107,"definition_similarity":39,"vector_similarity":108,"score":109},1618,"トノスコープ","14069000",0.0597015,0.722389,0.015873,[111,115,119,123,127,131,135,139,143,147,150,153],{"product_code":112,"device_name":113,"device_class":8,"k510_count":114},"JJY","Multi-Analyte Controls, All Kinds (Assayed)",673,{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"JJX","Single (Specified) Analyte Controls (Assayed And Unassayed)",493,{"product_code":120,"device_name":121,"device_class":8,"k510_count":122},"JJT","Enzyme Controls (Assayed And Unassayed)",97,{"product_code":124,"device_name":125,"device_class":8,"k510_count":126},"JJS","Controls For Blood-Gases, (Assayed And Unassayed)",67,{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"JJW","Urinalysis Controls (Assayed And Unassayed)",61,{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"JJR","Electrolyte Controls (Assayed And Unassayed)",17,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"MJX","Kit, Serological, Positive Control",7,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"MJZ","Kit, Direct Antigen, Positive Control",3,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"MJY","Kit, Serological, Negative Control",1,{"product_code":148,"device_name":149,"device_class":8,"k510_count":146},"OLD","Internal  Polymerase Chain Reaction  Control, Not Assay Specific",{"product_code":151,"device_name":152,"device_class":8,"k510_count":39},"MKA","Kit, Direct Antigen, Negative Control",{"product_code":154,"device_name":155,"device_class":8,"k510_count":39},"OHQ","Multi-Analyte Controls Unassayed",{"510k":157,"classification":158,"enforcement":159,"event":160,"pma":161,"warning_letter":162},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]