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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antigens, nontreponemal, all
510(k) Number K150358
Device Name Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Applicant
GOLD STANDARD DIAGNOSTICS
2851 SPAFFORD
DAVIS,  CA  95618
Applicant Contact NAPOLEON MONCE
Correspondent
GOLD STANDARD DIAGNOSTICS
2851 SPAFFORD
DAVIS,  CA  95618
Correspondent Contact NAPOLEON MONCE
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received02/12/2015
Decision Date 11/12/2015
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
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