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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 Thyroxine
510(k) Number K902922
Device Name MICROZYME T4 ENZYME IMMUNOASSAY KIT
Applicant
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Applicant Contact FRANCIS E CAPITANIO
Correspondent
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Correspondent Contact FRANCIS E CAPITANIO
Regulation Number862.1700
Classification Product Code
CDX  
Date Received07/03/1990
Decision Date 07/27/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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