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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroxine-Binding Globulin
510(k) Number K905777
Device Name MICROZYME THYROID UPTAKE ENZYME IMMUNOASSAY KIT
Applicant
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Applicant Contact FRANCIS CAPITANIO
Correspondent
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Correspondent Contact FRANCIS CAPITANIO
Regulation Number862.1685
Classification Product Code
CEE  
Date Received12/27/1990
Decision Date 01/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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