VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Radioimmunoassay, Follicle-stimulating Hormone

BIOMERIEUX VITEK, INC.

The following data is part of a premarket notification filed by Biomerieux Vitek, Inc. with the FDA for Vitek Immunodiagnostic Assay System.

Pre-market Notification Details

Device IDK921746
510k NumberK921746
Device Name:VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactVicki Anastasi
CorrespondentVicki Anastasi
BIOMERIEUX VITEK, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-04-13
Decision Date1992-06-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026156947 K921746 000

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