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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 K953160
Device Name OPUS T3
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact SHEILA KEADY
Correspondent
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact SHEILA KEADY
Regulation Number862.1710
Classification Product Code
CDP  
Subsequent Product Code
JIS  
Date Received07/07/1995
Decision Date 08/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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