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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 K820750
Device Name ENZYMUNE-TEST T4
Applicant
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ICL SCIENTIFIC
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1700
Classification Product Code
KLI  
Date Received03/19/1982
Decision Date 04/06/1982
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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