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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzyme linked immunoabsorption assay, treponema pallidum
510(k) Number K170413
Device Name BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set
Applicant
Bio-Rad Laboratories
5500 E. 2nd Street
Benicia,  CA  94510
Applicant Contact Juang Wang
Correspondent
Bio-Rad Laboratories
5500 E. 2nd Street
Benicia,  CA  94510
Correspondent Contact Juang Wang
Regulation Number866.3830
Classification Product Code
LIP  
Subsequent Product Codes
GMQ   JIT   JJX  
Date Received02/10/2017
Decision Date 05/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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