[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KQI":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":114,"syncDates":129},{"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":35,"updated_at":36,"recall_count":37,"latest_recall_date":38,"k510_count":39,"pma_count":37,"event_count":37},3674,"KQI","Assay, Fetal Hemoglobin","2","864.7455","HE","Hematology","1","",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":33,"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":34},{"k_number":17,"fei_number":22,"registration_number":30},[18,19,20,21],"K812226","K810475","K880653","K791143",[23,24,25,26,27,28,29],"3007490412","6387","3013513377","3002807968","3006198300","3023162659","1219029",[23,25,26,31,27,28,29],"8023024","N","Y","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,[],[42,50,57,65,72,79,86,93,100,107],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":37,"vector_similarity":48,"score":49},3552,"ヘモグロビン分析装置","Ⅰ","35481000",0.387097,0.733163,0.0327869,{"medical_device_id":51,"generic_name":52,"class_classification":45,"jmdn_code":53,"name_similarity":54,"definition_similarity":37,"vector_similarity":55,"score":56},3523,"グリコヘモグロビン分析装置","35968000",0.263158,0.703656,0.031498,{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":37,"vector_similarity":63,"score":64},1801,"胎児血液サンプラ","Ⅱ","32662000",0.162162,0.732054,0.0310544,{"medical_device_id":66,"generic_name":67,"class_classification":60,"jmdn_code":68,"name_similarity":69,"definition_similarity":37,"vector_similarity":70,"score":71},1569,"オキシヘモグロビン分析装置","33275000",0.277778,0.672068,0.0306218,{"medical_device_id":73,"generic_name":74,"class_classification":60,"jmdn_code":75,"name_similarity":76,"definition_similarity":37,"vector_similarity":77,"score":78},1526,"胎児心臓モニタ","43958000",0.153846,0.657241,0.0285773,{"medical_device_id":80,"generic_name":81,"class_classification":60,"jmdn_code":82,"name_similarity":83,"definition_similarity":37,"vector_similarity":84,"score":85},1420,"胎児超音波心音計","35068000",0.170213,0.646636,0.0281385,{"medical_device_id":87,"generic_name":88,"class_classification":60,"jmdn_code":89,"name_similarity":90,"definition_similarity":37,"vector_similarity":91,"score":92},2154,"胎児用頭皮採血キット","16873000",0.12766,0.688605,0.027972,{"medical_device_id":94,"generic_name":95,"class_classification":45,"jmdn_code":96,"name_similarity":97,"definition_similarity":37,"vector_similarity":98,"score":99},3554,"ヘモキシメトリック分析装置","37078000",0.125,0.696979,0.0277303,{"medical_device_id":101,"generic_name":102,"class_classification":45,"jmdn_code":103,"name_similarity":104,"definition_similarity":37,"vector_similarity":105,"score":106},3330,"胎児用聴診器","32659000",0.171429,0.625594,0.0274328,{"medical_device_id":108,"generic_name":109,"class_classification":60,"jmdn_code":110,"name_similarity":111,"definition_similarity":37,"vector_similarity":112,"score":113},1419,"胎児心音計","35067000",0.195122,0.619367,0.026861,[115,119,122,126],{"product_code":116,"device_name":117,"device_class":8,"k510_count":118},"GHQ","Stain, Fetal Hemoglobin",2,{"product_code":120,"device_name":121,"device_class":8,"k510_count":118},"LIM","Test, Screening, For D Positive Fetal Rbc'S",{"product_code":123,"device_name":124,"device_class":8,"k510_count":125},"JPC","Hemoglobin F Quantitation",1,{"product_code":127,"device_name":128,"device_class":8,"k510_count":37},"GHA","Hemoglobin, Alkali Resistant",{"510k":130,"classification":131,"enforcement":132,"event":133,"pma":134,"warning_letter":135},"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","2026-08-19T04:07:02.603+00:00"]