ENZYME-LINKED FLUORESCENT IMMUNOASSAY

Radioimmunoassay, Prolactin (lactogen)

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Enzyme-linked Fluorescent Immunoassay.

Pre-market Notification Details

Device IDK943811
510k NumberK943811
Device Name:ENZYME-LINKED FLUORESCENT IMMUNOASSAY
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactTerry Mcgovern
CorrespondentTerry Mcgovern
BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-05
Decision Date1994-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026156961 K943811 000

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