[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-LIB":3},{"classification":4,"mappedDevices":135,"similarCandidates":136,"relatedClassifications":209,"syncDates":311},{"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":128,"updated_at":129,"recall_count":130,"latest_recall_date":131,"k510_count":132,"pma_count":133,"event_count":134},6794,"LIB","Device, General Purpose, Microbiology, Diagnostic","1","866.2660","MI","Microbiology","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":126,"product_code":6,"review_panel":10,"gmp_exempt_flag":126,"third_party_flag":126,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":126,"medical_specialty_description":11,"summary_malfunction_reporting":127},{"k_number":17,"fei_number":61,"registration_number":116},[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],"K820346","K920416","K864249","K823557","K854423","K844476","K831450","K912558","K820345","K853285","K841937","K842052","K831642","K854603","K822960","K831658","K862112","K023677","K871559","K831641","K843483","K822962","K823833","K854604","K854602","K823787","K812068","K820043","K842057","K841390","K822292","K872273","K844442","K841632","K831643","K863789","K813640","K850725","K831448","K833131","K832117","K853745","K844473",[62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"3026241718","3012259842","2024311","3011527950","3032847781","3002807038","3020440077","3011649541","3013046485","3006440892","3000210101","2919016","3006224287","1221359","3030516433","3034669683","3003750284","3005735987","3008850249","1000136245","3010220595","3030178466","2244900","2150138","3005720829","1417592","2016673","2022807","3019387954","3007583567","3002806470","3002807578","3003703247","3011947913","3007135420","3009520931","3009974297","2023365","3042159574","3005273623","1924669","3042585783","1119779","3005670738","3003718445","3045058049","1000306431","3010278338","3014642322","3030125044","3010141591","3024463179","1000306617","3023809973",[62,63,64,65,66,117,68,70,71,73,75,77,76,118,78,119,79,80,84,82,83,85,86,87,88,89,90,120,121,122,91,92,94,95,96,97,98,99,100,101,102,103,104,106,107,123,124,125,109,110,111,112,113,115],"3003895930","2029372","9610649","8010096","3005360469","1423625","1528695","2029275","3009756327","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",13,"2025-11-19",43,0,8,[],[137,145,152,159,166,173,180,187,194,201],{"medical_device_id":138,"generic_name":139,"class_classification":140,"jmdn_code":141,"name_similarity":142,"definition_similarity":133,"vector_similarity":143,"score":144},1208,"ポータブルデジタル式汎用X線診断装置","Ⅱ","37643010",0.375,0.702646,0.0310096,{"medical_device_id":146,"generic_name":147,"class_classification":140,"jmdn_code":148,"name_similarity":149,"definition_similarity":133,"vector_similarity":150,"score":151},1214,"移動型デジタル式汎用X線診断装置","37647010",0.42029,0.695183,0.0306792,{"medical_device_id":153,"generic_name":154,"class_classification":140,"jmdn_code":155,"name_similarity":156,"definition_similarity":133,"vector_similarity":157,"score":158},1215,"移動型デジタル式汎用一体型X線診断装置","37647020",0.381579,0.691175,0.0295716,{"medical_device_id":160,"generic_name":161,"class_classification":140,"jmdn_code":162,"name_similarity":163,"definition_similarity":133,"vector_similarity":164,"score":165},3008,"汎用一体型X線診断装置用プログラム","37626042",0.346154,0.698746,0.0292735,{"medical_device_id":167,"generic_name":168,"class_classification":140,"jmdn_code":169,"name_similarity":170,"definition_similarity":133,"vector_similarity":171,"score":172},1204,"移動型アナログ式汎用X線診断装置","37626010",0.416667,0.683486,0.028629,{"medical_device_id":174,"generic_name":175,"class_classification":140,"jmdn_code":176,"name_similarity":177,"definition_similarity":133,"vector_similarity":178,"score":179},1220,"移動型アナログ式汎用一体型X線透視診断装置","37622020",0.32967,0.69824,0.0278097,{"medical_device_id":181,"generic_name":182,"class_classification":140,"jmdn_code":183,"name_similarity":184,"definition_similarity":133,"vector_similarity":185,"score":186},1212,"据置型デジタル式汎用X線診断装置","37645010",0.364865,0.683172,0.0271205,{"medical_device_id":188,"generic_name":189,"class_classification":140,"jmdn_code":190,"name_similarity":191,"definition_similarity":133,"vector_similarity":192,"score":193},1206,"ポータブルアナログ式汎用X線診断装置","37642010",0.373333,0.681027,0.0269162,{"medical_device_id":195,"generic_name":196,"class_classification":140,"jmdn_code":197,"name_similarity":198,"definition_similarity":133,"vector_similarity":199,"score":200},1209,"ポータブルデジタル式汎用一体型X線診断装置","37643020",0.341772,0.684425,0.0266856,{"medical_device_id":202,"generic_name":203,"class_classification":204,"jmdn_code":205,"name_similarity":206,"definition_similarity":133,"vector_similarity":207,"score":208},3247,"汎用X線診断装置用電動式患者台","Ⅰ","40655000",0.325301,0.692563,0.0262346,[210,214,218,222,226,230,234,238,242,245,249,252,256,260,263,267,270,273,277,280,284,288,292,295,298,302,305,308],{"product_code":211,"device_name":212,"device_class":8,"k510_count":213},"JTO","Discs, Strips And Reagents, Microorganism Differentiation",244,{"product_code":215,"device_name":216,"device_class":8,"k510_count":217},"JSS","Kit, Identification, Enterobacteriaceae",49,{"product_code":219,"device_name":220,"device_class":8,"k510_count":221},"JXA","Kit, Screening, Urine",44,{"product_code":223,"device_name":224,"device_class":8,"k510_count":225},"LLH","Reagents, Clostridium Difficile Toxin",42,{"product_code":227,"device_name":228,"device_class":8,"k510_count":229},"LJG","Quality Control Slides",27,{"product_code":231,"device_name":232,"device_class":8,"k510_count":233},"JWX","Kit, Screening, Staphylococcus Aureus",20,{"product_code":235,"device_name":236,"device_class":8,"k510_count":237},"JSP","Kit, Anaerobic Identification",18,{"product_code":239,"device_name":240,"device_class":8,"k510_count":241},"JSX","Kit, Identification, Neisseria Gonorrhoeae",16,{"product_code":243,"device_name":244,"device_class":8,"k510_count":241},"JXB","Kit, Identification, Yeast",{"product_code":246,"device_name":247,"device_class":8,"k510_count":248},"JWZ","Kit, Screening, Trichomonas",11,{"product_code":250,"device_name":251,"device_class":8,"k510_count":248},"LQL","Gram Positive Identification Panel",{"product_code":253,"device_name":254,"device_class":8,"k510_count":255},"MCB","Antigen, C. Difficile",10,{"product_code":257,"device_name":258,"device_class":8,"k510_count":259},"LQM","Gram Negative Identification Panel",7,{"product_code":261,"device_name":262,"device_class":8,"k510_count":259},"LSC","Neisseria Controls",{"product_code":264,"device_name":265,"device_class":8,"k510_count":266},"JST","Kit, Fastidious Organisms",6,{"product_code":268,"device_name":269,"device_class":8,"k510_count":266},"JSW","Kit, Identification, Glucose Nonfermenter",{"product_code":271,"device_name":272,"device_class":8,"k510_count":266},"JXC","Kit, Screening, Yeast",{"product_code":274,"device_name":275,"device_class":8,"k510_count":276},"JSY","Kit, Identification, Mycobacteria",5,{"product_code":278,"device_name":279,"device_class":8,"k510_count":276},"OMN","C. Difficile Nucleic Acid Amplification Test Assay",{"product_code":281,"device_name":282,"device_class":8,"k510_count":283},"LRH","Instrument For Auto Reader Of Overnight Microorganism Identification System",4,{"product_code":285,"device_name":286,"device_class":8,"k510_count":287},"NZS","Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast",3,{"product_code":289,"device_name":290,"device_class":8,"k510_count":291},"MJM","Dna Probe, Gardnerella Vaginalis",2,{"product_code":293,"device_name":294,"device_class":8,"k510_count":291},"MLA","Dna Probe, Yeast",{"product_code":296,"device_name":297,"device_class":8,"k510_count":291},"MXB","Test, Vaginal, Bacterial Sialidase",{"product_code":299,"device_name":300,"device_class":8,"k510_count":301},"JSR","Kit, Identification, Dermatophyte",1,{"product_code":303,"device_name":304,"device_class":8,"k510_count":301},"JSZ","Kit, Identification, Pseudomonas",{"product_code":306,"device_name":307,"device_class":8,"k510_count":301},"LTS","Test Reagents, Neisseria Gonorrhoeae Biochemical",{"product_code":309,"device_name":310,"device_class":8,"k510_count":301},"MJK","Dna Probe, Trichomonas Vaginalis",{"510k":312,"classification":313,"enforcement":314,"event":315,"pma":316,"warning_letter":317},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]