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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 NE 148th Terr.
North Miami,  FL  33181
Applicant Contact ROBERT A CORT
Correspondent
Quest Intl., Inc.
1938 NE 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
Predetermined Change
Control Plan Authorized		 No
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