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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 K821141
Device Name ENDAB T4 ENZYME IMMUNOASSAY KIT
Applicant
IMMUNOTECH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMMUNOTECH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1700
Classification Product Code
CDX  
Date Received04/21/1982
Decision Date 05/13/1982
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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