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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, test, thyroid autoantibody
510(k) Number K033977
Device Name ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG 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
JZO  
Date Received12/23/2003
Decision Date 03/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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