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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K940362
Device Name ANA SCREEN 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
LLL  
Date Received01/26/1994
Decision Date 07/28/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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