OPUS T3

Radioimmunoassay, Total Triiodothyronine

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Opus T3.

Pre-market Notification Details

Device IDK953160
510k NumberK953160
Device Name:OPUS T3
ClassificationRadioimmunoassay, Total Triiodothyronine
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactSheila Keady
CorrespondentSheila Keady
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeCDP  
CFR Regulation Number862.1710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-07
Decision Date1995-08-24

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