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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, free thyroxine
510(k) Number K940507
Device Name OPUS FT4 TEST SYSTEM
Applicant
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact NANCY M JOHANSEN
Correspondent
PB DIAGNOSTIC SYSTEMS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact NANCY M JOHANSEN
Regulation Number862.1695
Classification Product Code
CEC  
Date Received02/02/1994
Decision Date 07/28/1994
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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