[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-GHO":3},{"classification":4,"mappedDevices":66,"similarCandidates":67,"relatedClassifications":136,"syncDates":157,"translation":63,"marketSummary":63,"recalls":164,"k510s":166,"pmas":178},{"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":60,"updated_at":61,"recall_count":62,"latest_recall_date":63,"k510_count":64,"pma_count":62,"event_count":65},5909,"GHO","Hemocytometer","1","864.6160","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":58,"product_code":6,"review_panel":10,"gmp_exempt_flag":58,"third_party_flag":58,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":58,"medical_specialty_description":11,"summary_malfunction_reporting":59},{"k_number":17,"fei_number":20,"registration_number":51},[18,19],"K871671","K770980",[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],"3017450368","3008496560","2518612","3003799895","3004765453","3002757762","3009092698","3014150341","3008205331","3002539673","3009776283","1000522034","3019387954","3030733800","6585","3003393069","3007349751","3010402713","3005273623","3027645317","3010194621","3016090200","3009155756","3045058049","3003750510","3000251573","3043138885","3014053517","2410251","3043088937",[21,52,22,53,23,24,54,25,27,28,31,33,34,36,55,37,38,39,56,40,41,42,43,57,44,45,47,48,49,50],"2031824","8030108","9614577","9680411","1067123","2436787","N","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",0,null,2,1,[],[68,76,84,91,97,104,110,118,124,130],{"medical_device_id":69,"generic_name":70,"class_classification":71,"jmdn_code":72,"name_similarity":73,"definition_similarity":62,"vector_similarity":74,"score":75},1563,"黄疸計","Ⅱ","70078000",0.25,0.679678,0.0263158,{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":62,"vector_similarity":82,"score":83},3554,"ヘモキシメトリック分析装置","Ⅰ","37078000",0.2,0.695484,0.0251956,{"medical_device_id":85,"generic_name":86,"class_classification":79,"jmdn_code":87,"name_similarity":88,"definition_similarity":62,"vector_similarity":89,"score":90},3552,"ヘモグロビン分析装置","35481000",0.172414,0.750206,0.0163934,{"medical_device_id":92,"generic_name":93,"class_classification":79,"jmdn_code":94,"name_similarity":95,"definition_similarity":62,"vector_similarity":96,"score":90},3592,"フローサイトメータ","70193000",0.380952,0.61796,{"medical_device_id":98,"generic_name":99,"class_classification":71,"jmdn_code":100,"name_similarity":101,"definition_similarity":62,"vector_similarity":102,"score":103},2374,"体外循環用ヘマトクリットモニタ測定セル","70519000",0.0428571,0.743266,0.016129,{"medical_device_id":105,"generic_name":106,"class_classification":79,"jmdn_code":107,"name_similarity":108,"definition_similarity":62,"vector_similarity":109,"score":103},3403,"近点距離計","12821000",0.333333,0.644768,{"medical_device_id":111,"generic_name":112,"class_classification":113,"jmdn_code":114,"name_similarity":115,"definition_similarity":62,"vector_similarity":116,"score":117},707,"体外循環用ヘマトクリットモニタ","Ⅲ","70518000",0.0526316,0.741219,0.015873,{"medical_device_id":119,"generic_name":120,"class_classification":71,"jmdn_code":121,"name_similarity":122,"definition_similarity":62,"vector_similarity":123,"score":117},1427,"膀胱計","11111000",0.315789,0.600652,{"medical_device_id":125,"generic_name":126,"class_classification":79,"jmdn_code":127,"name_similarity":122,"definition_similarity":62,"vector_similarity":128,"score":129},3411,"ジストメータ","32741000",0.583113,0.015625,{"medical_device_id":131,"generic_name":132,"class_classification":79,"jmdn_code":133,"name_similarity":134,"definition_similarity":62,"vector_similarity":135,"score":129},3538,"ヘマトクリット分析装置","33328000",0.133333,0.73701,[137,141,144,147,151,154],{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"GJG","Pipette, Quantitative, Hematology",4,{"product_code":142,"device_name":143,"device_class":8,"k510_count":140},"GJW","Pipette, Pasteur",{"product_code":145,"device_name":146,"device_class":8,"k510_count":140},"GKM","Hand-Tally, Differential",{"product_code":148,"device_name":149,"device_class":8,"k510_count":150},"GLG","Platelet Counting, Manual",3,{"product_code":152,"device_name":153,"device_class":8,"k510_count":64},"GGX","Pipette, Sahli",{"product_code":155,"device_name":156,"device_class":8,"k510_count":62},"GGY","Pipette, Diluting",{"510k":158,"classification":159,"enforcement":160,"event":161,"pma":162,"warning_letter":163},"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","2026-08-20T03:28:02.95+00:00",{"items":165,"total":62},[],{"items":167,"total":64},[168,174],{"k_number":18,"device_name":169,"applicant":170,"decision_date":171,"clearance_type":172,"decision_code":173,"statement_or_summary":63},"URINOSCOPY FUNNEL","Portable Medical Laboratories, Inc.","1987-05-20","Traditional","SESE",{"k_number":19,"device_name":175,"applicant":176,"decision_date":177,"clearance_type":172,"decision_code":173,"statement_or_summary":63},"EMATOLOGY DILUENT RESERVOIR CLOSURE","Bd Becton Dickinson Vacutainer Systems Preanalytic","1977-07-11",{"items":179,"total":62},[]]