[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OBE":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":116,"syncDates":163},{"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},2670,"OBE","Anti-Ss-A 52 Autoantibodies","2","866.5100","IM","Immunology","1","The device is used for the detection, in human serum or plasma, of autoantibodies to SS-A 52.  The detection of SS-A 52 autoantibodies may aid in the diagnosis of systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, polymyositis and dermatomyositis.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":25,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":10,"gmp_exempt_flag":26,"third_party_flag":27,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":25,"life_sustain_support_flag":26,"medical_specialty_description":11,"summary_malfunction_reporting":28},{"k_number":17,"fei_number":21,"registration_number":24},[18,19,20],"K063565","K141655","K250814",[22,23],"3012348571","2026994",[22,23],"","N","Y","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-18T22:05:38.961415+00:00",0,null,3,[],[36,45,53,62,69,77,84,92,99,107],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":42,"vector_similarity":43,"score":44},3588,"自動染色装置","Ⅰ","70191000",0.111111,0.164557,0.605116,0.0275298,{"medical_device_id":46,"generic_name":47,"class_classification":39,"jmdn_code":48,"name_similarity":49,"definition_similarity":50,"vector_similarity":51,"score":52},3627,"再使用可能な自動ランセット","37243001",0.0869565,0.17301,0.615873,0.0245215,{"medical_device_id":54,"generic_name":55,"class_classification":56,"jmdn_code":57,"name_similarity":58,"definition_similarity":59,"vector_similarity":60,"score":61},1156,"マウス抗体使用冠動脈ステント","Ⅳ","47826004",0.153846,0.171617,0.554508,0.0163934,{"medical_device_id":63,"generic_name":64,"class_classification":39,"jmdn_code":65,"name_similarity":66,"definition_similarity":67,"vector_similarity":68,"score":61},3511,"移動式免疫蛍光分析装置","35707020",0.0357143,0.215278,0.6962,{"medical_device_id":70,"generic_name":71,"class_classification":39,"jmdn_code":72,"name_similarity":73,"definition_similarity":74,"vector_similarity":75,"score":76},3510,"免疫蛍光分析装置","35707010",0.0408163,0.20339,0.679278,0.016129,{"medical_device_id":78,"generic_name":79,"class_classification":39,"jmdn_code":80,"name_similarity":81,"definition_similarity":82,"vector_similarity":83,"score":76},3580,"微生物感受性分析装置","34574000",0.122449,0.186567,0.578869,{"medical_device_id":85,"generic_name":86,"class_classification":39,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},3506,"移動式酵素免疫測定装置","35706020",0.0350877,0.211155,0.652605,0.015873,{"medical_device_id":93,"generic_name":94,"class_classification":39,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":91},4189,"ガス式解剖用のこぎり","44144000",0.116279,0.155405,0.501728,{"medical_device_id":100,"generic_name":101,"class_classification":39,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":106},3509,"移動式免疫比濁分析装置","35926020",0.0344828,0.205882,0.6466,0.015625,{"medical_device_id":108,"generic_name":109,"class_classification":110,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},3175,"単回使用縫合器ガイド","Ⅱ","71054002",0.107143,0.188235,0.517371,0.0153846,[117,121,125,129,133,137,141,145,149,153,157,160],{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"LLL","Extractable Antinuclear Antibody, Antigen And Control",181,{"product_code":122,"device_name":123,"device_class":8,"k510_count":124},"LJM","Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls",112,{"product_code":126,"device_name":127,"device_class":8,"k510_count":128},"DHN","Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control",110,{"product_code":130,"device_name":131,"device_class":8,"k510_count":132},"LKJ","Antinuclear Antibody, Antigen, Control",50,{"product_code":134,"device_name":135,"device_class":8,"k510_count":136},"LRM","Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control",29,{"product_code":138,"device_name":139,"device_class":8,"k510_count":140},"LKP","Anti-Sm Antibody, Antigen And Control",28,{"product_code":142,"device_name":143,"device_class":8,"k510_count":144},"LKO","Anti-Rnp Antibody, Antigen And Control",23,{"product_code":146,"device_name":147,"device_class":8,"k510_count":148},"KTL","Anti-Dna Indirect Immunofluorescent Solid Phase",19,{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"LSW","Anti-Dna Antibody, Antigen And Control",8,{"product_code":154,"device_name":155,"device_class":8,"k510_count":156},"MQA","Anti-Ribosomal P Antibodies",4,{"product_code":158,"device_name":159,"device_class":8,"k510_count":156},"NYO","Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody",{"product_code":161,"device_name":162,"device_class":8,"k510_count":31},"PET","Anti-Ss-A Ro60 Autoantibodies",{"510k":164,"classification":165,"enforcement":166,"event":167,"pma":168,"warning_letter":169},"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"]