[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DLN":3},{"classification":4,"mappedDevices":30,"similarCandidates":31,"relatedClassifications":100,"syncDates":139},{"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":25,"updated_at":26,"recall_count":27,"latest_recall_date":28,"k510_count":29,"pma_count":27,"event_count":27},5343,"DLN","Hemagglutination, Cocaine Metabolites (Benzoylecgnonine)","2","862.3250","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":10,"gmp_exempt_flag":22,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"k_number":17},[18,19,20,21],"K760401","K792429","K924113","K950134","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,4,[],[32,40,47,54,61,68,75,81,88,93],{"medical_device_id":33,"generic_name":34,"class_classification":35,"jmdn_code":36,"name_similarity":37,"definition_similarity":27,"vector_similarity":38,"score":39},177,"ゼラチン使用吸収性局所止血材","Ⅳ","35895300",0.125,0.531875,0.0276506,{"medical_device_id":41,"generic_name":42,"class_classification":35,"jmdn_code":43,"name_similarity":44,"definition_similarity":27,"vector_similarity":45,"score":46},30,"ウロキナーゼ使用中心静脈用カテーテル","10729400",0.0340909,0.572941,0.0163934,{"medical_device_id":48,"generic_name":49,"class_classification":50,"jmdn_code":51,"name_similarity":52,"definition_similarity":27,"vector_similarity":53,"score":46},501,"二次治癒生理食塩液含有創傷被覆・保護材","Ⅲ","37298003",0.154762,0.445392,{"medical_device_id":55,"generic_name":56,"class_classification":50,"jmdn_code":57,"name_similarity":58,"definition_similarity":27,"vector_similarity":59,"score":60},431,"ウロキナーゼ使用緊急時ブラッドアクセス留置用カテーテル","70320400",0.0373832,0.553612,0.016129,{"medical_device_id":62,"generic_name":63,"class_classification":64,"jmdn_code":65,"name_similarity":66,"definition_similarity":27,"vector_similarity":67,"score":60},2248,"局所管理生理食塩液含有創傷被覆・保護材","Ⅱ","37298002",0.144578,0.458774,{"medical_device_id":69,"generic_name":70,"class_classification":50,"jmdn_code":71,"name_similarity":72,"definition_similarity":27,"vector_similarity":73,"score":74},427,"ウロキナーゼ使用血液透析用コアキシャルフロー型カテーテルイントロデューサキット","33799200",0.0980392,0.550533,0.015873,{"medical_device_id":76,"generic_name":77,"class_classification":64,"jmdn_code":78,"name_similarity":79,"definition_similarity":27,"vector_similarity":80,"score":74},1527,"子宮収縮モニタ","17922000",0.126761,0.353971,{"medical_device_id":82,"generic_name":83,"class_classification":35,"jmdn_code":84,"name_similarity":85,"definition_similarity":27,"vector_similarity":86,"score":87},1100,"ヒトトロンビン含有ゼラチン使用吸収性局所止血材","35895324",0.107843,0.547496,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":64,"jmdn_code":91,"name_similarity":79,"definition_similarity":27,"vector_similarity":92,"score":87},2978,"骨導式補聴器","33993000",0.372374,{"medical_device_id":94,"generic_name":95,"class_classification":50,"jmdn_code":96,"name_similarity":97,"definition_similarity":27,"vector_similarity":98,"score":99},761,"持続緩徐式血液濾過用装置","70541000",0.126582,0.499453,0.0153846,[101,105,109,113,117,121,124,127,130,133,136],{"product_code":102,"device_name":103,"device_class":8,"k510_count":104},"DIO","Enzyme Immunoassay, Cocaine And Cocaine Metabolites",145,{"product_code":106,"device_name":107,"device_class":8,"k510_count":108},"KLN","Radioimmunoassay, Cocaine Metabolite",14,{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"JXO","Enzyme Immunoassay, Cocaine",6,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"DMN","Thin Layer Chromatography, Cocaine",2,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"DIR","Free Radical Assay, Cocaine",1,{"product_code":122,"device_name":123,"device_class":8,"k510_count":27},"DIN","Gas Chromatography, Cocaine",{"product_code":125,"device_name":126,"device_class":8,"k510_count":27},"DNG","Free Radical, Benzoylecgnonine",{"product_code":128,"device_name":129,"device_class":8,"k510_count":27},"DOM","Thin Layer Chromatography, Benzoylecgnonine",{"product_code":131,"device_name":132,"device_class":8,"k510_count":27},"LAC","High Pressure Liquid Chromatography, Cocaine And Cocaine Metabolites",{"product_code":134,"device_name":135,"device_class":8,"k510_count":27},"NFY","Test, Cocaine And Cocaine Metabolites, Over The Counter",{"product_code":137,"device_name":138,"device_class":8,"k510_count":27},"PVA","Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt",{"510k":140,"classification":141,"enforcement":142,"event":143,"pma":144,"warning_letter":145},"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"]