[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-JKL":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":104,"syncDates":105,"translation":112,"marketSummary":118,"recalls":131,"k510s":133,"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":29,"updated_at":30,"recall_count":31,"latest_recall_date":32,"k510_count":33,"pma_count":31,"event_count":31},1368,"JKL","Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry","1","862.1060","CH","Clinical Chemistry","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":20,"registration_number":25},[18,19],"K842310","K921534",[21,22,23,24],"3021841051","3002706372","1000194896","3003385757",[22,26,21,24],"8043368","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.882786+00:00",0,null,2,[],[36,44,51,58,64,72,78,85,91,98],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":31,"vector_similarity":42,"score":43},2175,"熱交換機能付静脈内投与セット","Ⅱ","41609000",0.210526,0.542759,0.0163934,{"medical_device_id":45,"generic_name":46,"class_classification":47,"jmdn_code":48,"name_similarity":49,"definition_similarity":31,"vector_similarity":50,"score":43},3498,"イオン選択性分析装置","Ⅰ","35902000",0.0641026,0.622366,{"medical_device_id":52,"generic_name":53,"class_classification":39,"jmdn_code":54,"name_similarity":55,"definition_similarity":31,"vector_similarity":56,"score":57},2747,"歯科用アルミン酸セメント","70840000",0.178082,0.492035,0.016129,{"medical_device_id":59,"generic_name":60,"class_classification":47,"jmdn_code":61,"name_similarity":62,"definition_similarity":31,"vector_similarity":63,"score":57},3496,"炎光式電解質分析装置","35826000",0.0319149,0.614364,{"medical_device_id":65,"generic_name":66,"class_classification":67,"jmdn_code":68,"name_similarity":69,"definition_similarity":31,"vector_similarity":70,"score":71},110,"オキシメトリー用バルーン付カテーテル","Ⅳ","35856100",0.151899,0.507052,0.015873,{"medical_device_id":73,"generic_name":74,"class_classification":47,"jmdn_code":75,"name_similarity":76,"definition_similarity":31,"vector_similarity":77,"score":71},3514,"粒子計測免疫測定装置","70181000",0.0421053,0.609316,{"medical_device_id":79,"generic_name":80,"class_classification":67,"jmdn_code":81,"name_similarity":82,"definition_similarity":31,"vector_similarity":83,"score":84},111,"ヘパリン使用オキシメトリー用バルーン付カテーテル","35856200",0.141304,0.540175,0.015625,{"medical_device_id":86,"generic_name":87,"class_classification":47,"jmdn_code":88,"name_similarity":89,"definition_similarity":31,"vector_similarity":90,"score":84},3509,"移動式免疫比濁分析装置","35926020",0.0666667,0.609054,{"medical_device_id":92,"generic_name":93,"class_classification":39,"jmdn_code":94,"name_similarity":95,"definition_similarity":31,"vector_similarity":96,"score":97},2150,"交換輸血用輸血セット","35405000",0.1375,0.472606,0.0153846,{"medical_device_id":99,"generic_name":100,"class_classification":47,"jmdn_code":101,"name_similarity":102,"definition_similarity":31,"vector_similarity":103,"score":97},3503,"デンシトメトリー分析装置","15129000",0.0933333,0.608613,[],{"510k":106,"classification":107,"enforcement":108,"event":109,"pma":110,"warning_letter":111},"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":113,"definition_ja":32,"commentary_ja":114,"model_name":115,"source_hash":116,"reviewed_by":32,"reviewed_at":32,"created_at":117,"updated_at":117},"デルタアミノレブリン酸測定用イオン交換カラム（比色法）","この製品は米国においてクラスIに分類されており、市販前届出（510(k)）が免除される機器です。クラスIは一般的に人体へのリスクが低い機器に適用される区分であり、一般的な管理要件を満たすことで市販が認められています。","claude-sonnet-5","410b08da4911524394e66243db9d53282aa7acb8013dfa69a657df72be47c8ee","2026-08-24T02:01:22.211969+00:00",{"product_code":6,"summary_ja":119,"stats":120,"stats_hash":129,"model_name":115,"created_at":130,"updated_at":130},"本製品コードは510(k)届出免除のクラスI機器で、510(k)の累計件数は2件、参入企業数は2社となっており、直近5年間の届出は確認されていません。PMAの承認実績は確認されていません。不具合報告および回収についても、累計・直近5年ともに件数は確認されていません。",{"pma":121,"k510":122,"as_of":124,"events":125,"recalls":126,"top_problems":128},{"latest":32,"originals":31,"supplements":31},{"total":33,"last5y":31,"latest":123,"applicants":33},"1992-05-26","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":127},[],[],"e46ea2b570ec86b62894867a4895e960a04ba31c7a058b7b99f19fc4a8445f8f","2026-08-24T04:40:52.092694+00:00",{"items":132,"total":31},[],{"items":134,"total":33},[135,141],{"k_number":19,"device_name":136,"applicant":137,"decision_date":123,"clearance_type":138,"decision_code":139,"statement_or_summary":140},"DSL DHEA (DSL 8900)","Diagnostic Systems Laboratories, Inc.","Traditional","SESE","Statement",{"k_number":18,"device_name":142,"applicant":143,"decision_date":144,"clearance_type":138,"decision_code":139,"statement_or_summary":32},"HEMATOLOGY ANALYZER","Hml Inc\u002FBiotechnology Transfer","1984-09-06",{"items":146,"total":31},[]]