[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NRF":3},{"classification":4,"mappedDevices":43,"similarCandidates":44,"relatedClassifications":127,"syncDates":169},{"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":37,"updated_at":38,"recall_count":39,"latest_recall_date":40,"k510_count":41,"pma_count":42,"event_count":42},1978,"NRF","Material, Quality Control, Semen Analysis","2","864.8625","HE","Hematology","4","A semen analysis quality control material is a device used to determine the accuracy and precision of manual, semiautomated, and automated determinations of semen analysis parameters such as pH, sperm concentration, total sperm number, motility, morphology, vitality, and white blood cells.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":34,"device_class":8,"implant_flag":35,"product_code":6,"review_panel":10,"gmp_exempt_flag":35,"third_party_flag":35,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":34,"life_sustain_support_flag":35,"medical_specialty_description":11,"summary_malfunction_reporting":36},{"k_number":17,"fei_number":21,"registration_number":33},[18,19,20],"K042750","K041240","K041600",[22,23,24,25,26,27,28,29,30,31,32],"3008987086","3038206980","3003646592","1221433","3003750510","3035387168","1950302","3014053517","3043127699","2025606","3016090200",[22,23,24,25,26,27,28,29,30,31,32],"","N","Eligible","2026-08-18T05:52:49.347546+00:00","2026-08-18T22:05:38.961415+00:00",1,"2026-02-11",3,0,[],[45,54,62,71,79,87,95,103,112,119],{"medical_device_id":46,"generic_name":47,"class_classification":48,"jmdn_code":49,"name_similarity":50,"definition_similarity":51,"vector_similarity":52,"score":53},3590,"精子・精液分析装置","Ⅰ","36744000",0.25,0.269231,0.803046,0.0322665,{"medical_device_id":55,"generic_name":56,"class_classification":48,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},4449,"咀嚼能力検査用物質","71093001",0.206349,0.2,0.65961,0.0290832,{"medical_device_id":63,"generic_name":64,"class_classification":65,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":70},692,"透析用監視装置","Ⅲ","36424000",0.271186,0.163424,0.63465,0.0274927,{"medical_device_id":72,"generic_name":73,"class_classification":48,"jmdn_code":74,"name_similarity":75,"definition_similarity":76,"vector_similarity":77,"score":78},3582,"自動細胞診装置","70190000",0.203125,0.248869,0.643202,0.027151,{"medical_device_id":80,"generic_name":81,"class_classification":65,"jmdn_code":82,"name_similarity":83,"definition_similarity":84,"vector_similarity":85,"score":86},1030,"医薬品含有歯科用根管充填シーラ","70874000",0.272727,0.1875,0.522784,0.0163934,{"medical_device_id":88,"generic_name":89,"class_classification":48,"jmdn_code":90,"name_similarity":91,"definition_similarity":92,"vector_similarity":93,"score":94},3493,"パック式臨床化学分析装置","34550000",0.121212,0.229452,0.680415,0.016129,{"medical_device_id":96,"generic_name":97,"class_classification":48,"jmdn_code":98,"name_similarity":99,"definition_similarity":100,"vector_similarity":101,"score":102},3487,"移動式フロー方式臨床化学分析装置","35745020",0.128571,0.243169,0.665866,0.015873,{"medical_device_id":104,"generic_name":105,"class_classification":106,"jmdn_code":107,"name_similarity":108,"definition_similarity":109,"vector_similarity":110,"score":111},2794,"歯科用根管充填シーラ","Ⅱ","36095000",0.258621,0.171254,0.524134,0.015625,{"medical_device_id":113,"generic_name":114,"class_classification":48,"jmdn_code":115,"name_similarity":116,"definition_similarity":117,"vector_similarity":118,"score":111},3486,"フロー方式臨床化学分析装置","35745010",0.125,0.237968,0.662846,{"medical_device_id":120,"generic_name":121,"class_classification":106,"jmdn_code":122,"name_similarity":123,"definition_similarity":124,"vector_similarity":125,"score":126},2779,"歯科用シーリング・コーティング材","70860000",0.254545,0.178707,0.566822,0.0153846,[128,132,136,140,144,148,152,156,160,163,166],{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"JPK","Mixture, Hematology Quality Control",192,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"GGM","Control, Hemoglobin",15,{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"JCN","Control, Cell Counter, Normal And Abnormal",12,{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"GLQ","Mixture, Control, White-Cell And Red-Cell Indices",10,{"product_code":145,"device_name":146,"device_class":8,"k510_count":147},"GGL","Control, White-Cell",8,{"product_code":149,"device_name":150,"device_class":8,"k510_count":151},"GLK","Control, Hematocrit",7,{"product_code":153,"device_name":154,"device_class":8,"k510_count":155},"GJR","Control, Red-Cell",5,{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"GJP","Control, Platelet",4,{"product_code":161,"device_name":162,"device_class":8,"k510_count":39},"GFS","Standards And Controls, Hemoglobin, Normal And Abnormal",{"product_code":164,"device_name":165,"device_class":8,"k510_count":39},"NRS","Control Material, Blood Circulating Epithelial Cancer Cell",{"product_code":167,"device_name":168,"device_class":8,"k510_count":42},"MZG","Test, Residual, Wbc In Leukoreduced Blood",{"510k":170,"classification":171,"enforcement":172,"event":173,"pma":174,"warning_letter":175},"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"]