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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 immunoabsorbent assay, varicella-zoster
510(k) Number K070317
Device Name ZEUS SCIENTIFIC, INC VZV IGM ELISA 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 Number866.3900
Classification Product Code
LFY  
Date Received02/02/2007
Decision Date 07/05/2007
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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