[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-CHW":3},{"classification":4,"mappedDevices":36,"similarCandidates":37,"relatedClassifications":108,"syncDates":142},{"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":30,"updated_at":31,"recall_count":32,"latest_recall_date":33,"k510_count":34,"pma_count":32,"event_count":35},5061,"CHW","Titrimetric With Edta And Indicator, Calcium","2","862.1145","CH","Clinical Chemistry","1","",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":28,"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":29},{"k_number":17,"fei_number":21,"registration_number":25},[18,19,20],"K781454","K113521","K192730",[22,23,24],"2050012","2050010","3002806559",[23,26,22],"9610126","N","Y","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,107,[],[38,46,54,62,68,75,81,88,94,102],{"medical_device_id":39,"generic_name":40,"class_classification":41,"jmdn_code":42,"name_similarity":43,"definition_similarity":32,"vector_similarity":44,"score":45},3499,"カルシウム分析装置","Ⅰ","35937000",0.2,0.694111,0.0327869,{"medical_device_id":47,"generic_name":48,"class_classification":49,"jmdn_code":50,"name_similarity":51,"definition_similarity":32,"vector_similarity":52,"score":53},822,"チタニウムアダプタ","Ⅲ","70588000",0.153846,0.602508,0.0258592,{"medical_device_id":55,"generic_name":56,"class_classification":57,"jmdn_code":58,"name_similarity":59,"definition_similarity":32,"vector_similarity":60,"score":61},1253,"単一エネルギー骨X線吸収測定装置","Ⅱ","37625010",0.0375,0.649421,0.016129,{"medical_device_id":63,"generic_name":64,"class_classification":57,"jmdn_code":65,"name_similarity":66,"definition_similarity":32,"vector_similarity":67,"score":61},1610,"純音聴力検査及び語音聴覚検査機能付インピーダンスオージオメータ","36717020",0.183908,0.552044,{"medical_device_id":69,"generic_name":70,"class_classification":57,"jmdn_code":71,"name_similarity":72,"definition_similarity":32,"vector_similarity":73,"score":74},1254,"単一エネルギー骨X線吸収測定一体型装置","37625020",0.0574713,0.64803,0.015873,{"medical_device_id":76,"generic_name":77,"class_classification":57,"jmdn_code":78,"name_similarity":79,"definition_similarity":32,"vector_similarity":80,"score":74},3075,"純音聴力検査及び語音聴覚検査機能付インピーダンスオージオメータ用プログラム","36717042",0.177083,0.555318,{"medical_device_id":82,"generic_name":83,"class_classification":57,"jmdn_code":84,"name_similarity":85,"definition_similarity":32,"vector_similarity":86,"score":87},1256,"二重エネルギー骨X線吸収測定一体型装置","37661020",0.0595238,0.645376,0.015625,{"medical_device_id":89,"generic_name":90,"class_classification":41,"jmdn_code":91,"name_similarity":92,"definition_similarity":32,"vector_similarity":93,"score":87},3743,"再使用可能な指示薬注入器","31736001",0.175439,0.563326,{"medical_device_id":95,"generic_name":96,"class_classification":97,"jmdn_code":98,"name_similarity":99,"definition_similarity":32,"vector_similarity":100,"score":101},110,"オキシメトリー用バルーン付カテーテル","Ⅳ","35856100",0.174603,0.549898,0.0153846,{"medical_device_id":103,"generic_name":104,"class_classification":41,"jmdn_code":105,"name_similarity":106,"definition_similarity":32,"vector_similarity":107,"score":101},3519,"浸透圧分析装置","36458000",0.125,0.643141,[109,113,117,121,125,128,132,136,139],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"CIC","Cresolphthalein Complexone, Calcium",99,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"CJY","Azo Dye, Calcium",47,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"JFP","Electrode, Ion Specific, Calcium",29,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"CIA","Methylthymol Blue, Calcium",5,{"product_code":126,"device_name":127,"device_class":8,"k510_count":34},"JFN","Atomic Absorption, Calcium",{"product_code":129,"device_name":130,"device_class":8,"k510_count":131},"CID","Alizarin Sulfonate, Calcium",2,{"product_code":133,"device_name":134,"device_class":8,"k510_count":135},"CHZ","Di (O-Hydroxyphenylimine) Ethane, Calcium",1,{"product_code":137,"device_name":138,"device_class":8,"k510_count":135},"JFO","Fluorometric, Calcium",{"product_code":140,"device_name":141,"device_class":8,"k510_count":32},"CHC","Titrimetric Permanganate And Bromophenol Blue, Calcium",{"510k":143,"classification":144,"enforcement":145,"event":146,"pma":147,"warning_letter":148},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]