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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Total Triiodothyronine
510(k) Number K904820
Device Name MICROZYME T3 ENZYME IMMUNOASSAY KIT
Applicant
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Applicant Contact FRANCIS E CAPITANIO
Correspondent
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Correspondent Contact FRANCIS E CAPITANIO
Regulation Number862.1710
Classification Product Code
CDP  
Date Received10/24/1990
Decision Date 12/18/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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