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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 K771623
Device Name T3 RIA
Original Applicant
HOFFMANN-LA ROCHE, INC.
Regulation Number862.1710
Classification Product Code
CDP  
Date Received08/25/1977
Decision Date 09/20/1977
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
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