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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-2
510(k) Number K103603
Device Name ZEUS ELISA HSV GG-2 IGG TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Applicant Contact EWA NADOLCZAK
Correspondent
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Correspondent Contact EWA NADOLCZAK
Regulation Number866.3305
Classification Product Code
MYF  
Date Received12/08/2010
Decision Date 05/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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