[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-DGJ":3},{"classification":4,"mappedDevices":26,"similarCandidates":27,"relatedClassifications":100,"syncDates":101,"translation":108,"marketSummary":114,"recalls":127,"k510s":129,"pmas":136},{"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":21,"updated_at":22,"recall_count":23,"latest_recall_date":24,"k510_count":25,"pma_count":23,"event_count":23},3960,"DGJ","Colostrum, Antigen, Antiserum, Control","1","866.5230","IM","Immunology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":19,"product_code":6,"review_panel":10,"gmp_exempt_flag":19,"third_party_flag":19,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":19,"medical_specialty_description":11,"summary_malfunction_reporting":20},{"k_number":17},[18],"K890689","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:48.758894+00:00",0,null,1,[],[28,36,44,51,58,65,73,80,87,94],{"medical_device_id":29,"generic_name":30,"class_classification":31,"jmdn_code":32,"name_similarity":33,"definition_similarity":23,"vector_similarity":34,"score":35},2487,"ウォーターパッド加温装置コントロールユニット","Ⅱ","36956010",0.156863,0.577479,0.029907,{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":23,"vector_similarity":42,"score":43},3277,"X線自動露出制御器","Ⅰ","34311000",0.173077,0.562253,0.0291385,{"medical_device_id":45,"generic_name":46,"class_classification":39,"jmdn_code":47,"name_similarity":48,"definition_similarity":23,"vector_similarity":49,"score":50},4288,"結腸瘻ロッド","31987000",0.166667,0.562767,0.0283816,{"medical_device_id":52,"generic_name":53,"class_classification":39,"jmdn_code":54,"name_similarity":55,"definition_similarity":23,"vector_similarity":56,"score":57},3589,"低温温度制御装置","16538000",0.169811,0.555524,0.0274254,{"medical_device_id":59,"generic_name":60,"class_classification":31,"jmdn_code":61,"name_similarity":62,"definition_similarity":23,"vector_similarity":63,"score":64},2174,"輸液セット用コントローラ","36244000",0.160714,0.554358,0.0256536,{"medical_device_id":66,"generic_name":67,"class_classification":68,"jmdn_code":69,"name_similarity":70,"definition_similarity":23,"vector_similarity":71,"score":72},666,"コラーゲン使用体内用失禁補綴材","Ⅲ","34214200",0.147059,0.562546,0.0256034,{"medical_device_id":74,"generic_name":75,"class_classification":68,"jmdn_code":76,"name_similarity":77,"definition_similarity":23,"vector_similarity":78,"score":79},1125,"植込み能動型機器管理用プログラム","71052003",0.15873,0.54988,0.0248097,{"medical_device_id":81,"generic_name":82,"class_classification":31,"jmdn_code":83,"name_similarity":84,"definition_similarity":23,"vector_similarity":85,"score":86},2446,"酸素コントローラ","70577000",0.243243,0.505058,0.0163934,{"medical_device_id":88,"generic_name":89,"class_classification":31,"jmdn_code":90,"name_similarity":91,"definition_similarity":23,"vector_similarity":92,"score":93},1917,"短期的使用乳児用経腸栄養キット","36044002",0.0147059,0.576686,0.016129,{"medical_device_id":95,"generic_name":96,"class_classification":39,"jmdn_code":97,"name_similarity":98,"definition_similarity":23,"vector_similarity":99,"score":93},3578,"コロニー定量分析装置","15126000",0.1875,0.499872,[],{"510k":102,"classification":103,"enforcement":104,"event":105,"pma":106,"warning_letter":107},"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":109,"definition_ja":24,"commentary_ja":110,"model_name":111,"source_hash":112,"reviewed_by":24,"reviewed_at":24,"created_at":113,"updated_at":113},"初乳抗原抗血清コントロール","本品は、初乳中の抗原に対する抗血清を用いた免疫学的検査における精度管理用のコントロール製品です。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、既存の同種機器との実質的同等性を個別に審査する必要がないと判断されるほど、安全性および有効性に関するリスクが低い機器であることを意味します。","claude-sonnet-5","d5c25f7c02dd34cb8360261571d6ef66475cfb96b55aa3275112947cde1474ab","2026-08-24T01:46:26.815929+00:00",{"product_code":6,"summary_ja":115,"stats":116,"stats_hash":125,"model_name":111,"created_at":126,"updated_at":126},"本製品コードは届出免除区分であり、510(k)の累計件数は1件、参入企業数は1社にとどまり、直近5年間の届出実績は確認されていません。不具合報告（MDR）は累計0件であり、報告は確認されていません。回収についても累計0件で、クラスI・II・IIIいずれの区分でも該当はなく、直近5年間の回収も確認されていません。",{"pma":117,"k510":118,"as_of":120,"events":121,"recalls":122,"top_problems":124},{"latest":24,"originals":23,"supplements":23},{"total":25,"last5y":23,"latest":119,"applicants":25},"1989-08-25","2026-08",{"death":23,"other":23,"total":23,"injury":23,"last5y":23,"malfunction":23,"latest_month":24},{"total":23,"last5y":23,"latest":24,"class_i":23,"class_ii":23,"class_iii":23,"top_root_causes":123},[],[],"7ea7f323f1b45514f1fbdef429cb146db055aaa67be2fd2ded8fba4e56c56a1e","2026-08-24T04:11:59.548648+00:00",{"items":128,"total":23},[],{"items":130,"total":25},[131],{"k_number":18,"device_name":132,"applicant":133,"decision_date":119,"clearance_type":134,"decision_code":135,"statement_or_summary":24},"ADX TM OPIATES","Abbott Laboratories","Traditional","SESE",{"items":137,"total":23},[]]