[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KZS":3},{"classification":4,"mappedDevices":29,"similarCandidates":30,"relatedClassifications":101,"syncDates":134,"translation":141,"marketSummary":147,"recalls":160,"k510s":162,"pmas":164},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":12,"submission_type_id":13,"definition":14,"implant_flag":15,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":24,"updated_at":25,"recall_count":26,"latest_recall_date":27,"k510_count":26,"pma_count":26,"event_count":28},3803,"KZS","Chromatography (Thin Layer), Clinical Use","1","862.2270","CH","Clinical Chemistry","TX","4","",false,{"openfda":17,"definition":14,"device_name":7,"review_code":14,"device_class":8,"implant_flag":22,"product_code":6,"review_panel":12,"gmp_exempt_flag":22,"third_party_flag":22,"medical_specialty":10,"regulation_number":9,"submission_type_id":13,"unclassified_reason":14,"life_sustain_support_flag":22,"medical_specialty_description":11,"summary_malfunction_reporting":23},{"fei_number":18,"registration_number":21},[19,20],"2245285","3002800697",[19,20],"N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-24T02:00:47.318533+00:00",0,null,6,[],[31,39,46,53,60,67,74,81,87,94],{"medical_device_id":32,"generic_name":33,"class_classification":34,"jmdn_code":35,"name_similarity":36,"definition_similarity":26,"vector_similarity":37,"score":38},3492,"乾式臨床化学分析装置","Ⅰ","34549000",0.192982,0.66744,0.0325225,{"medical_device_id":40,"generic_name":41,"class_classification":34,"jmdn_code":42,"name_similarity":43,"definition_similarity":26,"vector_similarity":44,"score":45},3518,"高速液体クロマトグラフィ分析装置","36420000",0.246377,0.652326,0.0317781,{"medical_device_id":47,"generic_name":48,"class_classification":34,"jmdn_code":49,"name_similarity":50,"definition_similarity":26,"vector_similarity":51,"score":52},3486,"フロー方式臨床化学分析装置","35745010",0.186441,0.666177,0.031746,{"medical_device_id":54,"generic_name":55,"class_classification":34,"jmdn_code":56,"name_similarity":57,"definition_similarity":26,"vector_similarity":58,"score":59},3493,"パック式臨床化学分析装置","34550000",0.180328,0.654836,0.0310096,{"medical_device_id":61,"generic_name":62,"class_classification":34,"jmdn_code":63,"name_similarity":64,"definition_similarity":26,"vector_similarity":65,"score":66},3487,"移動式フロー方式臨床化学分析装置","35745020",0.166667,0.667372,0.0302135,{"medical_device_id":68,"generic_name":69,"class_classification":34,"jmdn_code":70,"name_similarity":71,"definition_similarity":26,"vector_similarity":72,"score":73},3488,"ディスクリート方式臨床化学自動分析装置","35743010",0.185714,0.618641,0.0297095,{"medical_device_id":75,"generic_name":76,"class_classification":34,"jmdn_code":77,"name_similarity":78,"definition_similarity":26,"vector_similarity":79,"score":80},3490,"遠心方式臨床化学分析装置","35744010",0.171875,0.626029,0.0292111,{"medical_device_id":82,"generic_name":83,"class_classification":34,"jmdn_code":84,"name_similarity":64,"definition_similarity":26,"vector_similarity":85,"score":86},3527,"ポータブル臨床用屈折計","37034000",0.617223,0.0277778,{"medical_device_id":88,"generic_name":89,"class_classification":34,"jmdn_code":90,"name_similarity":91,"definition_similarity":26,"vector_similarity":92,"score":93},3491,"移動式遠心方式臨床化学分析装置","35744020",0.15493,0.640723,0.0270563,{"medical_device_id":95,"generic_name":96,"class_classification":34,"jmdn_code":97,"name_similarity":98,"definition_similarity":26,"vector_similarity":99,"score":100},3489,"移動式ディスクリート方式臨床化学自動分析装置","35743020",0.164557,0.611337,0.0265191,[102,106,110,113,116,119,122,125,128,131],{"product_code":103,"device_name":104,"device_class":8,"k510_count":105},"DPA","Apparatus, General Use, Thin Layer Chromatography",5,{"product_code":107,"device_name":108,"device_class":8,"k510_count":109},"DJS","U.V. Light, Tlc",1,{"product_code":111,"device_name":112,"device_class":8,"k510_count":109},"DKG","Plate, Cellulose, Tlc",{"product_code":114,"device_name":115,"device_class":8,"k510_count":109},"DKK","Tanks, Developing, Tlc",{"product_code":117,"device_name":118,"device_class":8,"k510_count":26},"DJO","Indicator, Cellulose Fluorescent, Tlc",{"product_code":120,"device_name":121,"device_class":8,"k510_count":26},"DKS","Plate, Silica Gel, Tlc",{"product_code":123,"device_name":124,"device_class":8,"k510_count":26},"DKY","Indicator, Alumina Fluorescent, Tlc",{"product_code":126,"device_name":127,"device_class":8,"k510_count":26},"DLC","Atomizer, Tlc",{"product_code":129,"device_name":130,"device_class":8,"k510_count":26},"DLO","Indicator, Silica Gel Fluorescent, Tlc",{"product_code":132,"device_name":133,"device_class":8,"k510_count":26},"DLY","Plate, Alumina, Tlc",{"510k":135,"classification":136,"enforcement":137,"event":138,"pma":139,"warning_letter":140},"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":142,"definition_ja":27,"commentary_ja":143,"model_name":144,"source_hash":145,"reviewed_by":27,"reviewed_at":27,"created_at":146,"updated_at":146},"臨床用薄層クロマトグラフィー装置","本品は、臨床検体中に含まれる化学物質や代謝産物を薄層クロマトグラフィーの原理により分離・同定するための装置です。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、他のクラスII・III機器と比較して安全性・有効性に関するリスクが低いと判断されているためです。","claude-sonnet-5","06c48f61895e274593d980452642529d05da5332bbeecf4da18ee6e2ba78833d","2026-08-24T02:10:16.590298+00:00",{"product_code":6,"summary_ja":148,"stats":149,"stats_hash":158,"model_name":144,"created_at":159,"updated_at":159},"本製品は届出免除（510(k) Exempt）のクラスI医療機器であり、510(k)およびPMAの承認・届出実績は確認されていません。不具合報告は累計約6件で、すべてMalfunction(不具合)として報告されており、死亡・傷害の報告は確認されていません。回収についても累計0件であり、クラスIを含め該当する事例は確認されていません。",{"pma":150,"k510":151,"as_of":152,"events":153,"recalls":155,"top_problems":157},{"latest":27,"originals":26,"supplements":26},{"total":26,"last5y":26,"latest":27,"applicants":26},"2026-08",{"death":26,"other":26,"total":28,"injury":26,"last5y":26,"malfunction":28,"latest_month":154},"2006-12",{"total":26,"last5y":26,"latest":27,"class_i":26,"class_ii":26,"class_iii":26,"top_root_causes":156},[],[],"edec9d9abafcfbac676806a51d92530cab647ce02b0346cbd2dea83a53a96487","2026-08-24T04:49:04.081036+00:00",{"items":161,"total":26},[],{"items":163,"total":26},[],{"items":165,"total":26},[]]