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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K872192
Device Name IMMUBEAD T4 ENZYME IMMUNOASSAY KIT
Applicant
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Applicant Contact E CAPITANIO
Correspondent
IMMUNOTECH CORP.
90 WINDOM STREET, PO BOX 860
BOSTON,  MA  02134
Correspondent Contact E CAPITANIO
Regulation Number862.1700
Classification Product Code
KLI  
Date Received06/08/1987
Decision Date 08/13/1987
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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