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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 K771142
Device Name T3 CLASP RIA KIT
Applicant
E. R. SQUIBB & SONS, INC.
40 W 57TH ST.
NEW YORK,  NY  10019
Correspondent
E. R. SQUIBB & SONS, INC.
40 W 57TH ST.
NEW YORK,  NY  10019
Regulation Number862.1710
Classification Product Code
CDP  
Date Received06/27/1977
Decision Date 07/14/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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