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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 Triiodothyronine
510(k) Number K802883
Device Name T3-SQUIBB RIA KIT
Applicant
E. R. SQUIBB & SONS, INC.
GEORGES RD.
NEW BRUNSWICK,  NJ 
Correspondent
E. R. SQUIBB & SONS, INC.
GEORGES RD.
NEW BRUNSWICK,  NJ 
Regulation Number862.1710
Classification Product Code
CDP  
Date Received11/17/1980
Decision Date 12/19/1980
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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