[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KSZ":3},{"classification":4,"mappedDevices":70,"similarCandidates":71,"relatedClassifications":143,"syncDates":150},{"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":64,"updated_at":65,"recall_count":66,"latest_recall_date":67,"k510_count":68,"pma_count":66,"event_count":69},2638,"KSZ","System, Test, Automated Blood Grouping And Antibody","2","864.9175","HE","Hematology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":62,"product_code":6,"review_panel":10,"gmp_exempt_flag":62,"third_party_flag":62,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":62,"medical_specialty_description":11,"summary_malfunction_reporting":63},{"k_number":17,"fei_number":22,"registration_number":52},[18,19,20,21],"K790282","K810899","K771098","K770185",[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],"1643621","3003966680","1217454","3020460367","1034569","1000086912","3002807663","3003783142","3004910133","3002806595","3002772505","3003402518","3012963943","3006003617","1000132079","3002642396","3000308930","2250051","3013557562","3008244372","3002865632","3003460312","3014643041","3021186226","1000136573","3006421415","3003413192","3006198300","3016014873",[23,53,24,25,26,54,27,55,30,31,33,34,35,56,57,58,38,39,40,41,42,59,45,46,48,60,50,61,51],"1056600","9610824","3002807090","2032600","8043379","1319681","9612296","1531264","3000236920","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-19T02:30:42.714273+00:00",0,null,4,10399,[],[72,80,87,94,101,108,116,123,129,136],{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":66,"vector_similarity":78,"score":79},3569,"血液型分析装置","Ⅰ","35635000",0.276923,0.759668,0.0322665,{"medical_device_id":81,"generic_name":82,"class_classification":75,"jmdn_code":83,"name_similarity":84,"definition_similarity":66,"vector_similarity":85,"score":86},3577,"血液培養自動分析装置","35617000",0.274194,0.6955,0.0305504,{"medical_device_id":88,"generic_name":89,"class_classification":75,"jmdn_code":90,"name_similarity":91,"definition_similarity":66,"vector_similarity":92,"score":93},3572,"自動尿スクリーニングシステム","30648000",0.316667,0.671748,0.0295513,{"medical_device_id":95,"generic_name":96,"class_classification":75,"jmdn_code":97,"name_similarity":98,"definition_similarity":66,"vector_similarity":99,"score":100},3541,"血液像自動分析装置","35479000",0.202703,0.70338,0.0294691,{"medical_device_id":102,"generic_name":103,"class_classification":75,"jmdn_code":104,"name_similarity":105,"definition_similarity":66,"vector_similarity":106,"score":107},3588,"自動染色装置","70191000",0.216667,0.67833,0.0287785,{"medical_device_id":109,"generic_name":110,"class_classification":111,"jmdn_code":112,"name_similarity":113,"definition_similarity":66,"vector_similarity":114,"score":115},1808,"健康検診システム","Ⅱ","70178000",0.191176,0.690079,0.0278261,{"medical_device_id":117,"generic_name":118,"class_classification":111,"jmdn_code":119,"name_similarity":120,"definition_similarity":66,"vector_similarity":121,"score":122},2042,"自己輸血装置用チューブ","42924000",0.289855,0.597526,0.016129,{"medical_device_id":124,"generic_name":125,"class_classification":75,"jmdn_code":126,"name_similarity":127,"definition_similarity":66,"vector_similarity":128,"score":122},3539,"手動式血球計数装置","35103000",0.139241,0.717846,{"medical_device_id":130,"generic_name":131,"class_classification":75,"jmdn_code":132,"name_similarity":133,"definition_similarity":66,"vector_similarity":134,"score":135},3514,"粒子計測免疫測定装置","70181000",0.0617284,0.711862,0.015873,{"medical_device_id":137,"generic_name":138,"class_classification":75,"jmdn_code":139,"name_similarity":140,"definition_similarity":66,"vector_similarity":141,"score":142},3537,"血球計数装置","35476000",0.125,0.710436,0.015625,[144,147],{"product_code":145,"device_name":146,"device_class":8,"k510_count":66},"OQX","Self-Contained Blood Grouping ",{"product_code":148,"device_name":149,"device_class":8,"k510_count":66},"PBC","Manual Blood Grouping And Antibody Test Systems",{"510k":151,"classification":152,"enforcement":153,"event":154,"pma":155,"warning_letter":156},"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"]