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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 K770156
Device Name SPAC TM T4 RIA KIT
Applicant
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MALLINCKRODT CRITICAL CARE
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1700
Classification Product Code
CDX  
Date Received01/24/1977
Decision Date 02/07/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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