[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LCR":3},{"classification":4,"mappedDevices":58,"similarCandidates":59,"relatedClassifications":130,"syncDates":150},{"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":52,"updated_at":53,"recall_count":54,"latest_recall_date":55,"k510_count":56,"pma_count":54,"event_count":57},382,"LCR","Fluorescent Immunoassay, Tobramycin","2","862.3900","TX","Clinical Toxicology","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":49,"product_code":6,"review_panel":10,"gmp_exempt_flag":49,"third_party_flag":50,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":49,"medical_specialty_description":11,"summary_malfunction_reporting":51},{"k_number":17,"fei_number":35,"registration_number":47},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34],"K810941","K850058","K802668","K962818","K801308","K974029","K822197","K813542","K911940","K952568","K911613","K832408","K060998","K854873","K840847","K821542","K820130",[36,37,38,39,40,41,42,43,44,45,46],"3007019572","2050010","3003561301","3033967997","2432235","1219913","2517506","3006198300","3005333358","2050012","3010939897",[37,38,39,40,41,42,48,43,44,45,46],"8020888","N","Y","Eligible","2026-08-18T05:52:47.660896+00:00","2026-08-18T22:05:38.961415+00:00",0,null,17,6,[],[60,68,75,81,88,95,102,109,116,123],{"medical_device_id":61,"generic_name":62,"class_classification":63,"jmdn_code":64,"name_similarity":65,"definition_similarity":54,"vector_similarity":66,"score":67},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.347826,0.673835,0.0327869,{"medical_device_id":69,"generic_name":70,"class_classification":63,"jmdn_code":71,"name_similarity":72,"definition_similarity":54,"vector_similarity":73,"score":74},3511,"移動式免疫蛍光分析装置","35707020",0.301887,0.66564,0.032002,{"medical_device_id":76,"generic_name":77,"class_classification":63,"jmdn_code":78,"name_similarity":79,"definition_similarity":54,"vector_similarity":80,"score":74},3512,"免疫発光測定装置","36223010",0.303571,0.640009,{"medical_device_id":82,"generic_name":83,"class_classification":63,"jmdn_code":84,"name_similarity":85,"definition_similarity":54,"vector_similarity":86,"score":87},3513,"移動式免疫発光測定装置","36223020",0.269841,0.632813,0.0310096,{"medical_device_id":89,"generic_name":90,"class_classification":63,"jmdn_code":91,"name_similarity":92,"definition_similarity":54,"vector_similarity":93,"score":94},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.232143,0.628583,0.03031,{"medical_device_id":96,"generic_name":97,"class_classification":63,"jmdn_code":98,"name_similarity":99,"definition_similarity":54,"vector_similarity":100,"score":101},3514,"粒子計測免疫測定装置","70181000",0.193548,0.624365,0.028665,{"medical_device_id":103,"generic_name":104,"class_classification":63,"jmdn_code":105,"name_similarity":106,"definition_similarity":54,"vector_similarity":107,"score":108},3555,"ラジオイムノアッセイ用装置","35506000",0.196078,0.616919,0.0284045,{"medical_device_id":110,"generic_name":111,"class_classification":63,"jmdn_code":112,"name_similarity":113,"definition_similarity":54,"vector_similarity":114,"score":115},3505,"酵素免疫測定装置","35706010",0.235294,0.600702,0.0281385,{"medical_device_id":117,"generic_name":118,"class_classification":63,"jmdn_code":119,"name_similarity":120,"definition_similarity":54,"vector_similarity":121,"score":122},3506,"移動式酵素免疫測定装置","35706020",0.206897,0.591703,0.0264808,{"medical_device_id":124,"generic_name":125,"class_classification":63,"jmdn_code":126,"name_similarity":127,"definition_similarity":54,"vector_similarity":128,"score":129},3567,"イムノアッセイ用検体前処理装置","30870000",0.230769,0.58025,0.0262001,[131,135,139,143,147],{"product_code":132,"device_name":133,"device_class":8,"k510_count":134},"KLB","Radioimmunoassay, Tobramycin",23,{"product_code":136,"device_name":137,"device_class":8,"k510_count":138},"LFW","Fluorescence Polarization Immunoassay, Tobramycin",10,{"product_code":140,"device_name":141,"device_class":8,"k510_count":142},"DID","Bacillus Subtilis Microbiology Assay, Tobramycin",5,{"product_code":144,"device_name":145,"device_class":8,"k510_count":146},"LDO","Enzymatic Radiochemical Assay, Tobramycin",3,{"product_code":148,"device_name":149,"device_class":8,"k510_count":54},"KZX","Kit, Disc, Agar Gel Diffusion, Determine Serum Levels Of Tobramycin",{"510k":151,"classification":152,"enforcement":153,"event":154,"pma":155,"warning_letter":156},"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"]