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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 K905410
Device Name OPUS T3 TEST SYSTEM
Applicant
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number862.1710
Classification Product Code
CDP  
Date Received12/03/1990
Decision Date 02/04/1991
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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