[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JBN":3},{"classification":4,"mappedDevices":32,"similarCandidates":33,"relatedClassifications":105,"syncDates":106,"translation":113,"marketSummary":119,"recalls":132,"k510s":134,"pmas":145},{"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":27,"updated_at":28,"recall_count":29,"latest_recall_date":30,"k510_count":31,"pma_count":29,"event_count":29},1111,"JBN","Fibrin Monomer Paracoagulation","2","864.7300","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":25,"product_code":6,"review_panel":10,"gmp_exempt_flag":25,"third_party_flag":25,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":25,"medical_specialty_description":11,"summary_malfunction_reporting":26},{"k_number":17,"fei_number":20,"registration_number":23},[18,19],"K854015","K781814",[21,22],"2245451","3003565434",[21,24],"9710666","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:47.808424+00:00",0,null,2,[],[34,42,50,57,64,71,78,85,92,99],{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":29,"vector_similarity":40,"score":41},1089,"自己検査用血液凝固分析器","Ⅲ","56687003",0.258065,0.633883,0.0322581,{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":29,"vector_similarity":48,"score":49},3543,"血液凝固分析装置","Ⅰ","35514000",0.234043,0.635345,0.0320184,{"medical_device_id":51,"generic_name":52,"class_classification":37,"jmdn_code":53,"name_similarity":54,"definition_similarity":29,"vector_similarity":55,"score":56},735,"ヘパリン使用体外循環用血液学的パラメータモニタ向け測定セル","70528000",0.215909,0.612455,0.0284848,{"medical_device_id":58,"generic_name":59,"class_classification":37,"jmdn_code":60,"name_similarity":61,"definition_similarity":29,"vector_similarity":62,"score":63},919,"眼科用レーザ光凝固・パルスレーザ手術装置","70636000",0.164384,0.60246,0.0244484,{"medical_device_id":65,"generic_name":66,"class_classification":45,"jmdn_code":67,"name_similarity":68,"definition_similarity":29,"vector_similarity":69,"score":70},3542,"凝固測定用経過時間タイマ","35505000",0.324324,0.558829,0.0163934,{"medical_device_id":72,"generic_name":73,"class_classification":37,"jmdn_code":74,"name_similarity":75,"definition_similarity":29,"vector_similarity":76,"score":77},733,"体外循環用血液学的パラメータモニタ","70526000",0.242424,0.563529,0.015873,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":29,"vector_similarity":84,"score":77},1100,"ヒトトロンビン含有ゼラチン使用吸収性局所止血材","Ⅳ","35895324",0.0454545,0.626383,{"medical_device_id":86,"generic_name":87,"class_classification":37,"jmdn_code":88,"name_similarity":89,"definition_similarity":29,"vector_similarity":90,"score":91},547,"ヘパリン使用一時留置型人工血管","70487103",0.0705882,0.626054,0.015625,{"medical_device_id":93,"generic_name":94,"class_classification":81,"jmdn_code":95,"name_similarity":96,"definition_similarity":29,"vector_similarity":97,"score":98},45,"ヘパリン使用冠動脈灌流用カテーテル","34914200",0.126984,0.622537,0.0153846,{"medical_device_id":100,"generic_name":101,"class_classification":37,"jmdn_code":102,"name_similarity":103,"definition_similarity":29,"vector_similarity":104,"score":98},734,"体外循環用血液学的パラメータモニタ測定セル","70527000",0.217949,0.55096,[],{"510k":107,"classification":108,"enforcement":109,"event":110,"pma":111,"warning_letter":112},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":114,"definition_ja":30,"commentary_ja":115,"model_name":116,"source_hash":117,"reviewed_by":30,"reviewed_at":30,"created_at":118,"updated_at":118},"フィブリンモノマー傍凝固検査用機器","本品は米国FDAの分類においてクラスIIに区分される医療機器です。クラスIIに分類される機器は一般に中程度のリスクを有するとされますが、本品は市販前届出（510(k)）が免除されている点が特徴です。","claude-sonnet-5","5698c072e0c1ed94770374bdf43c10e54a36826520026c84438a30620c18e9b8","2026-08-24T02:01:22.211969+00:00",{"product_code":6,"summary_ja":120,"stats":121,"stats_hash":130,"model_name":116,"created_at":131,"updated_at":131},"本製品分類は届出免除（510(k) Exempt）の区分であり、510(k)は累計2件、参入企業数は2社で、直近5年の届出はありません。不具合報告および回収については、いずれも累計件数が0件であり、確認されていません。",{"pma":122,"k510":123,"as_of":125,"events":126,"recalls":127,"top_problems":129},{"latest":30,"originals":29,"supplements":29},{"total":31,"last5y":29,"latest":124,"applicants":31},"1986-03-06","2026-08",{"death":29,"other":29,"total":29,"injury":29,"last5y":29,"malfunction":29,"latest_month":30},{"total":29,"last5y":29,"latest":30,"class_i":29,"class_ii":29,"class_iii":29,"top_root_causes":128},[],[],"8ad95242a9fddb14f3178d1f615a35815ab9fd5ac3c16c1959755d3dd2422997","2026-08-24T04:40:52.092694+00:00",{"items":133,"total":29},[],{"items":135,"total":31},[136,141],{"k_number":18,"device_name":137,"applicant":138,"decision_date":124,"clearance_type":139,"decision_code":140,"statement_or_summary":30},"FS TEST KIT","American Bioproducts Co.","Traditional","SESE",{"k_number":19,"device_name":142,"applicant":143,"decision_date":144,"clearance_type":139,"decision_code":140,"statement_or_summary":30},"SULFATE, FIBRIQUIK PROTAMINE","General Diagnostics","1978-11-08",{"items":146,"total":29},[]]