VIDAS ESTRADIOL II (E2II) ASSAY

Radioimmunoassay, Estradiol

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vidas Estradiol Ii (e2ii) Assay.

Pre-market Notification Details

Device IDK955647
510k NumberK955647
Device Name:VIDAS ESTRADIOL II (E2II) ASSAY
ClassificationRadioimmunoassay, Estradiol
Applicant BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactTerry Mcgovern
CorrespondentTerry Mcgovern
BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeCHP  
CFR Regulation Number862.1260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-12
Decision Date1996-02-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026161637 K955647 000

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