[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JBZ":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":108,"syncDates":109,"translation":116,"marketSummary":122,"recalls":135,"k510s":137,"pmas":151},{"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":31},6725,"JBZ","Study, Platelet Adhesive","2","864.6650","HE","Hematology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":27,"product_code":6,"review_panel":10,"gmp_exempt_flag":27,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":27,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":21,"registration_number":24},[18,19,20],"K771523","K800037","K771678",[22,23],"1000119305","1317628",[25,26],"1313525","1932180","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-24T02:00:47.949024+00:00",0,null,3,[],[36,44,52,59,66,74,81,88,94,101],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":31,"vector_similarity":42,"score":43},3815,"皮膚バリア粘着プレート","Ⅰ","31071000",0.405405,0.691182,0.0327869,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":31,"vector_similarity":50,"score":51},180,"軟組織接合用接着剤","Ⅳ","34164100",0.285714,0.690206,0.032002,{"medical_device_id":53,"generic_name":54,"class_classification":39,"jmdn_code":55,"name_similarity":56,"definition_similarity":31,"vector_similarity":57,"score":58},4429,"救急絆創膏","34864000",0.28125,0.659872,0.03031,{"medical_device_id":60,"generic_name":61,"class_classification":39,"jmdn_code":62,"name_similarity":63,"definition_similarity":31,"vector_similarity":64,"score":65},3795,"皮膚用接着剤","33492101",0.357143,0.648787,0.0294624,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":31,"vector_similarity":72,"score":73},2715,"歯科レジン用接着材料","Ⅱ","70816000",0.25,0.656698,0.0294118,{"medical_device_id":75,"generic_name":76,"class_classification":47,"jmdn_code":77,"name_similarity":78,"definition_similarity":31,"vector_similarity":79,"score":80},178,"アルブミン使用接着剤","33492204",0.214286,0.683295,0.02886,{"medical_device_id":82,"generic_name":83,"class_classification":39,"jmdn_code":84,"name_similarity":85,"definition_similarity":31,"vector_similarity":86,"score":87},3546,"血小板凝集測定装置","35473000",0.232558,0.661735,0.0288501,{"medical_device_id":89,"generic_name":90,"class_classification":69,"jmdn_code":91,"name_similarity":56,"definition_similarity":31,"vector_similarity":92,"score":93},2810,"義歯床安定用糊材","16388009",0.636627,0.0287829,{"medical_device_id":95,"generic_name":96,"class_classification":69,"jmdn_code":97,"name_similarity":98,"definition_similarity":31,"vector_similarity":99,"score":100},2759,"歯科用象牙質接着材","42483002",0.264706,0.634646,0.0281385,{"medical_device_id":102,"generic_name":103,"class_classification":47,"jmdn_code":104,"name_similarity":105,"definition_similarity":31,"vector_similarity":106,"score":107},179,"動脈瘤形成術用組織接着剤","33511000",0.195652,0.670539,0.0279707,[],{"510k":110,"classification":111,"enforcement":112,"event":113,"pma":114,"warning_letter":115},"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":117,"definition_ja":32,"commentary_ja":118,"model_name":119,"source_hash":120,"reviewed_by":32,"reviewed_at":32,"created_at":121,"updated_at":121},"血小板粘着能検査装置","この製品は、血液中の血小板が異物表面に付着する性質（粘着能）を調べるための検査用機器です。米国ではクラスIIに分類されていますが、510(k)の届出が免除されており、市販前届出を行うことなく市場に流通させることが可能です。","claude-sonnet-5","5cfa77829e02dd0217ea9aa8fddbc1fc092069dd6d2bc5fe26159aa44d3a3686","2026-08-24T02:01:22.211969+00:00",{"product_code":6,"summary_ja":123,"stats":124,"stats_hash":133,"model_name":119,"created_at":134,"updated_at":134},"本製品コードでは、510(k)の累計件数は3件、参入企業数は3社となっており、直近5年間の届出はありません。不具合報告(MDR)および回収の実績は確認されていません。PMAによる承認実績もありません。",{"pma":125,"k510":126,"as_of":128,"events":129,"recalls":130,"top_problems":132},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":127,"applicants":33},"1980-02-05","2026-08",{"death":31,"other":31,"total":31,"injury":31,"last5y":31,"malfunction":31,"latest_month":32},{"total":31,"last5y":31,"latest":32,"class_i":31,"class_ii":31,"class_iii":31,"top_root_causes":131},[],[],"207ee12b54754500c09985648c567142382d3fbc63a665f7a6e0effb8d254100","2026-08-24T04:40:52.092694+00:00",{"items":136,"total":31},[],{"items":138,"total":33},[139,144,148],{"k_number":19,"device_name":140,"applicant":141,"decision_date":127,"clearance_type":142,"decision_code":143,"statement_or_summary":32},"PLATELET RETENTION (ADHESION) COLUMNS","Hemometrix","Traditional","SESE",{"k_number":20,"device_name":145,"applicant":146,"decision_date":147,"clearance_type":142,"decision_code":143,"statement_or_summary":32},"THROMBO-SCREEN PLATELET ADHESION","Bay Area Hema. Onco. Clinic. & Res. L","1977-11-22",{"k_number":18,"device_name":149,"applicant":150,"decision_date":147,"clearance_type":142,"decision_code":143,"statement_or_summary":32},"LATELET RETENTION COLUMN","Bd Becton Dickinson Vacutainer Systems Preanalytic",{"items":152,"total":31},[]]