[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CJD":3},{"classification":4,"mappedDevices":27,"similarCandidates":28,"relatedClassifications":99,"syncDates":123},{"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":22,"updated_at":23,"recall_count":24,"latest_recall_date":25,"k510_count":26,"pma_count":24,"event_count":24},6051,"CJD","Nitrosalicylate Reduction, Amylase","2","862.1070","CH","Clinical Chemistry","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":20,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":21},{"k_number":17},[18],"K915704","N","Y","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-18T22:05:38.961415+00:00",0,null,1,[],[29,37,45,52,59,66,72,79,86,93],{"medical_device_id":30,"generic_name":31,"class_classification":32,"jmdn_code":33,"name_similarity":34,"definition_similarity":24,"vector_similarity":35,"score":36},332,"病原体不活化・減少システム","Ⅲ","44185000",0.172414,0.54541,0.031498,{"medical_device_id":38,"generic_name":39,"class_classification":40,"jmdn_code":41,"name_similarity":42,"definition_similarity":24,"vector_similarity":43,"score":44},2279,"脂肪吸引器","Ⅱ","36894000",0.136364,0.52048,0.0244444,{"medical_device_id":46,"generic_name":47,"class_classification":40,"jmdn_code":48,"name_similarity":49,"definition_similarity":24,"vector_similarity":50,"score":51},2911,"眼圧減圧器","15048000",0.0877193,0.565197,0.0163934,{"medical_device_id":53,"generic_name":54,"class_classification":55,"jmdn_code":56,"name_similarity":57,"definition_similarity":24,"vector_similarity":58,"score":51},3276,"X線被曝低減装置","Ⅰ","70037000",0.185185,0.500119,{"medical_device_id":60,"generic_name":61,"class_classification":40,"jmdn_code":62,"name_similarity":63,"definition_similarity":24,"vector_similarity":64,"score":65},1832,"導入針","70194000",0.177778,0.361099,0.016129,{"medical_device_id":67,"generic_name":68,"class_classification":55,"jmdn_code":69,"name_similarity":70,"definition_similarity":24,"vector_similarity":71,"score":65},4202,"アデノトーム","10025000",0.0238095,0.564345,{"medical_device_id":73,"generic_name":74,"class_classification":55,"jmdn_code":75,"name_similarity":76,"definition_similarity":24,"vector_similarity":77,"score":78},3517,"ラクテート分析装置","35885000",0.0638298,0.55569,0.015873,{"medical_device_id":80,"generic_name":81,"class_classification":40,"jmdn_code":82,"name_similarity":83,"definition_similarity":24,"vector_similarity":84,"score":85},2300,"手術用吸引器レギュレータ","37003000",0.166667,0.477203,0.015625,{"medical_device_id":87,"generic_name":88,"class_classification":40,"jmdn_code":89,"name_similarity":90,"definition_similarity":24,"vector_similarity":91,"score":92},2301,"胸腔吸引器レギュレータ","37782000",0.160714,0.4509,0.0153846,{"medical_device_id":94,"generic_name":95,"class_classification":40,"jmdn_code":96,"name_similarity":97,"definition_similarity":24,"vector_similarity":98,"score":92},2836,"電動式ケラトーム","12222002",0.0204082,0.544996,[100,104,108,112,116,120],{"product_code":101,"device_name":102,"device_class":8,"k510_count":103},"JFJ","Catalytic Methods, Amylase",99,{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"CIJ","Saccharogenic, Amylase",31,{"product_code":109,"device_name":110,"device_class":8,"k510_count":111},"CJA","Amyloclastic, Amylase",10,{"product_code":113,"device_name":114,"device_class":8,"k510_count":115},"CIW","Starch-Dye Bound Polymer, Amylase",8,{"product_code":117,"device_name":118,"device_class":8,"k510_count":119},"KHM","Nephelometric, Amylase",6,{"product_code":121,"device_name":122,"device_class":8,"k510_count":24},"CIK","Radial Diffusion, Amylase",{"510k":124,"classification":125,"enforcement":126,"event":127,"pma":128,"warning_letter":129},"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"]