[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JNF":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":102,"syncDates":103,"translation":110,"marketSummary":116,"recalls":129,"k510s":131,"pmas":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":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":28,"pma_count":26,"event_count":26},1343,"JNF","Ion-Exchange Resin, Ehrlich'S Reagent, Porphobilinogen","1","862.1590","CH","Clinical Chemistry","4","",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":22,"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":23},{"k_number":17,"fei_number":19,"registration_number":21},[18],"K961984",[20],"1832216",[20],"N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:49.169481+00:00",0,null,1,[],[31,39,46,53,60,67,73,80,88,95],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":26,"vector_similarity":37,"score":38},2730,"暫間義歯床用レジン","Ⅱ","70828000",0.114286,0.626107,0.027365,{"medical_device_id":40,"generic_name":41,"class_classification":34,"jmdn_code":42,"name_similarity":43,"definition_similarity":26,"vector_similarity":44,"score":45},2799,"歯科用暫間修復向けグラスポリアルケノエート系レジンセメント","70880000",0.122642,0.600771,0.0261717,{"medical_device_id":47,"generic_name":48,"class_classification":34,"jmdn_code":49,"name_similarity":50,"definition_similarity":26,"vector_similarity":51,"score":52},2732,"義歯床用軟性レジン","70830000",0.123077,0.588601,0.0239316,{"medical_device_id":54,"generic_name":55,"class_classification":34,"jmdn_code":56,"name_similarity":57,"definition_similarity":26,"vector_similarity":58,"score":59},2773,"歯科充填用グラスポリアルケノエート系レジンセメント","70854002",0.117021,0.588842,0.0231407,{"medical_device_id":61,"generic_name":62,"class_classification":34,"jmdn_code":63,"name_similarity":64,"definition_similarity":26,"vector_similarity":65,"score":66},2457,"局所灌流用熱交換器","13318000",0.188406,0.53726,0.0163934,{"medical_device_id":68,"generic_name":69,"class_classification":34,"jmdn_code":70,"name_similarity":71,"definition_similarity":26,"vector_similarity":72,"score":66},2600,"歯科用イオン導入装置","70703000",0.09375,0.635824,{"medical_device_id":74,"generic_name":75,"class_classification":34,"jmdn_code":76,"name_similarity":77,"definition_similarity":26,"vector_similarity":78,"score":79},2150,"交換輸血用輸血セット","35405000",0.176471,0.4751,0.016129,{"medical_device_id":81,"generic_name":82,"class_classification":83,"jmdn_code":84,"name_similarity":85,"definition_similarity":26,"vector_similarity":86,"score":87},298,"コラーゲン使用腹膜カテーテル用吸収性カフ","Ⅳ","70589200",0.0412371,0.617607,0.015873,{"medical_device_id":89,"generic_name":90,"class_classification":91,"jmdn_code":92,"name_similarity":93,"definition_similarity":26,"vector_similarity":94,"score":87},4110,"歯科印象トレー用レジン","Ⅰ","70832000",0.149254,0.562787,{"medical_device_id":96,"generic_name":97,"class_classification":34,"jmdn_code":98,"name_similarity":99,"definition_similarity":26,"vector_similarity":100,"score":101},2175,"熱交換機能付静脈内投与セット","41609000",0.142857,0.529172,0.015625,[],{"510k":104,"classification":105,"enforcement":106,"event":107,"pma":108,"warning_letter":109},"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":111,"definition_ja":27,"commentary_ja":112,"model_name":113,"source_hash":114,"reviewed_by":27,"reviewed_at":27,"created_at":115,"updated_at":115},"ポルフォビリノゲン用イオン交換樹脂・エールリッヒ試薬","本品は、尿中のポルフォビリノゲンをイオン交換樹脂とエールリッヒ試薬を用いて検出・測定するための臨床化学検査用試薬キットです。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これはリスクが低く、一般的な管理要件のみで市販が可能と判断されている機器であることを意味します。","claude-sonnet-5","a9c79956361dd292e3d6d1d3d4b4ddbd90b33b4c98642e097dbf922d768fce0b","2026-08-24T02:01:22.211969+00:00",{"product_code":6,"summary_ja":117,"stats":118,"stats_hash":127,"model_name":113,"created_at":128,"updated_at":128},"本製品コード（JNF）は届出免除の対象で、510(k)の累計件数は1件のみとなっており、直近5年間の新規届出は確認されていません。参入企業数は1社です。回収については累計0件で、クラスI・II・IIIいずれも確認されていません。不具合報告（MDR）についても累計0件であり、死亡・傷害・不具合の報告は確認されていません。",{"pma":119,"k510":120,"as_of":122,"events":123,"recalls":124,"top_problems":126},{"latest":27,"originals":26,"supplements":26},{"total":28,"last5y":26,"latest":121,"applicants":28},"1996-12-10","2026-08",{"death":26,"other":26,"total":26,"injury":26,"last5y":26,"malfunction":26,"latest_month":27},{"total":26,"last5y":26,"latest":27,"class_i":26,"class_ii":26,"class_iii":26,"top_root_causes":125},[],[],"124505d1f714ed332ad510fbfc0591aa49cea3c3c68e3bd98520f9f0fdc58be1","2026-08-24T04:43:14.552546+00:00",{"items":130,"total":26},[],{"items":132,"total":28},[133],{"k_number":18,"device_name":134,"applicant":135,"decision_date":121,"clearance_type":136,"decision_code":137,"statement_or_summary":138},"PORPHOBILINOGEN (PBG)","Trace America, Inc.","Traditional","SESE","Statement",{"items":140,"total":26},[]]