[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-KLI":3},{"classification":4,"mappedDevices":171,"similarCandidates":172,"relatedClassifications":244,"syncDates":249},{"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":164,"updated_at":165,"recall_count":166,"latest_recall_date":167,"k510_count":168,"pma_count":169,"event_count":170},600,"KLI","Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine","2","862.1700","CH","Clinical Chemistry","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":162,"product_code":6,"review_panel":10,"gmp_exempt_flag":162,"third_party_flag":162,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":162,"medical_specialty_description":11,"summary_malfunction_reporting":163},{"k_number":17,"fei_number":104,"registration_number":150},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"K801475","K840241","K971269","K981377","K800384","K782085","K781828","K951014","K926475","K932605","K820750","K082638","K962211","K896982","K841576","K160495","K911217","K830136","K982298","K972974","K834102","K897193","K942575","K946163","K874866","K896865","K854971","K000600","K830769","K873976","K823034","K920712","K023369","K991432","K910261","K915194","K770070","K852164","K841601","K823751","K903095","K922433","K953837","K880620","K890831","K810586","K884634","K131515","K030860","K971203","K921904","K952751","K983440","K790686","K872192","K951321","K896329","K943019","K885258","K103484","K834210","K926393","K873518","K801288","K971709","K862233","K912616","K874603","K881357","K897144","K001603","K884260","K840473","K897072","K830683","K790848","K941042","K880662","K802693","K935880","K944703","K884700","K964721","K892853","K950588","K885141",[105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149],"3003795116","1036362","1832216","3002808498","1827821","3002808328","2122870","1000122044","3009518015","3010939897","2967","2245285","3005529799","3002809144","2432235","3050015","3005094123","3003261083","3010825766","2050012","3009984016","3022178699","2050010","1181055","3012963943","3007111389","1219913","3003952975","3002642396","3000308930","2250051","3002800697","3003030793","3005333358","2020726","3002806560","1000121039","1000136573","2517506","3002806944","3006198300","3002806559","3014325803","1000306617","3005984081",[151,105,106,107,109,111,152,113,153,154,114,116,155,117,118,156,119,120,121,123,124,125,157,126,128,129,127,158,130,131,159,160,133,134,135,136,137,138,139,161,143,144,145,149,147],"9615037","8043909","9612316","9610529","2029372","1222302","9610126","2247288","8031673","1319681","2032682","N","Eligible","2026-08-18T05:52:48.222586+00:00","2026-08-18T22:05:38.961415+00:00",12,"2026-04-29",86,0,24,[],[173,181,188,194,201,208,215,222,229,236],{"medical_device_id":174,"generic_name":175,"class_classification":176,"jmdn_code":177,"name_similarity":178,"definition_similarity":169,"vector_similarity":179,"score":180},3505,"酵素免疫測定装置","Ⅰ","35706010",0.316667,0.687441,0.0320184,{"medical_device_id":182,"generic_name":183,"class_classification":176,"jmdn_code":184,"name_similarity":185,"definition_similarity":169,"vector_similarity":186,"score":187},3506,"移動式酵素免疫測定装置","35706020",0.283582,0.69017,0.032002,{"medical_device_id":189,"generic_name":190,"class_classification":176,"jmdn_code":191,"name_similarity":192,"definition_similarity":169,"vector_similarity":193,"score":187},3555,"ラジオイムノアッセイ用装置","35506000",0.241935,0.713616,{"medical_device_id":195,"generic_name":196,"class_classification":176,"jmdn_code":197,"name_similarity":198,"definition_similarity":169,"vector_similarity":199,"score":200},3556,"イムノアッセイ用シンチレーションカウンタ","34567000",0.180556,0.641107,0.0299107,{"medical_device_id":202,"generic_name":203,"class_classification":176,"jmdn_code":204,"name_similarity":205,"definition_similarity":169,"vector_similarity":206,"score":207},3512,"免疫発光測定装置","36223010",0.171053,0.638353,0.0290404,{"medical_device_id":209,"generic_name":210,"class_classification":176,"jmdn_code":211,"name_similarity":212,"definition_similarity":169,"vector_similarity":213,"score":214},3513,"移動式免疫発光測定装置","36223020",0.156627,0.639027,0.0290099,{"medical_device_id":216,"generic_name":217,"class_classification":176,"jmdn_code":218,"name_similarity":219,"definition_similarity":169,"vector_similarity":220,"score":221},3567,"イムノアッセイ用検体前処理装置","30870000",0.176471,0.622496,0.0282051,{"medical_device_id":223,"generic_name":224,"class_classification":176,"jmdn_code":225,"name_similarity":226,"definition_similarity":169,"vector_similarity":227,"score":228},3514,"粒子計測免疫測定装置","70181000",0.153846,0.630995,0.0280392,{"medical_device_id":230,"generic_name":231,"class_classification":176,"jmdn_code":232,"name_similarity":233,"definition_similarity":169,"vector_similarity":234,"score":235},3535,"酵素分析装置","35470000",0.116667,0.632645,0.0268468,{"medical_device_id":237,"generic_name":238,"class_classification":239,"jmdn_code":240,"name_similarity":241,"definition_similarity":169,"vector_similarity":242,"score":243},1286,"甲状腺摂取率測定用核医学装置","Ⅱ","40648000",0.0869565,0.71673,0.0163934,[245],{"product_code":246,"device_name":247,"device_class":8,"k510_count":248},"CDX","Radioimmunoassay, Total Thyroxine",121,{"510k":250,"classification":251,"enforcement":252,"event":253,"pma":254,"warning_letter":255},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]