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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antibodies, Gliadin
510(k) Number K990204
Device Name GLIADIN IGG 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 Number866.5750
Classification Product Code
MST  
Date Received01/21/1999
Decision Date 03/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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