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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 K023592
Device Name SERAQUEST ANTI-THYROGLOBULIN
Applicant
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI,  FL  33181
Applicant Contact ROBERT A CORT
Correspondent
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI,  FL  33181
Correspondent Contact ROBERT A CORT
Regulation Number866.5870
Classification Product Code
DDC  
Date Received10/25/2002
Decision Date 01/06/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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