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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thyroglobulin, Antigen, Antiserum, Control
510(k) Number K991179
Device Name ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
Applicant
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Applicant Contact MARK J KOPNITSKY
Correspondent
Zeus Scientific, Inc.
200 Evans Way
Branchburg,  NJ  08876
Correspondent Contact MARK J KOPNITSKY
Regulation Number866.5870
Classification Product Code
DDC  
Date Received04/07/1999
Decision Date 06/17/1999
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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