COBAS(R) CORE FT4 EIA

Radioimmunoassay, Free Thyroxine

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Cobas(r) Core Ft4 Eia.

Pre-market Notification Details

Device IDK932607
510k NumberK932607
Device Name:COBAS(R) CORE FT4 EIA
ClassificationRadioimmunoassay, Free Thyroxine
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactRita Smith
CorrespondentRita Smith
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeCEC  
CFR Regulation Number862.1695 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-05-28
Decision Date1994-01-24

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