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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 Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
510(k) Number K131334
Device Name HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
Applicant
Gold Standard Diagnostics
2851 Spafford St.
Davis,  CA  95618
Applicant Contact NAPLEON MONCE
Correspondent
Gold Standard Diagnostics
2851 Spafford St.
Davis,  CA  95618
Correspondent Contact NAPLEON MONCE
Regulation Number866.3305
Classification Product Code
MXJ  
Date Received05/09/2013
Decision Date 02/28/2014
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
Predetermined Change
Control Plan Authorized		 No
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