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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name antinuclear antibody (enzyme-labeled), antigen, controls
510(k) Number K941409
Device Name ENA PROFILE-6 ELISA TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Applicant Contact MARK J KOPNITSKY
Correspondent
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.5100
Classification Product Code
LJM  
Date Received03/23/1994
Decision Date 06/10/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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