COBAS CORE PROLACTIN EIA

Radioimmunoassay, Prolactin (lactogen)

ROCHE DIAGNOSTIC SYSTEMS, INC.

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

Pre-market Notification Details

Device IDK930305
510k NumberK930305
Device Name:COBAS CORE PROLACTIN EIA
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
ContactCarol L.krieger
CorrespondentCarol L.krieger
ROCHE DIAGNOSTIC SYSTEMS, INC. 1080 U.S. HIGHWAY 202 Branchburg,  NJ  08876 -3771
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-21
Decision Date1993-08-19

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