VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA

Enzyme Linked Immunoabsorbent Assay, Mumps Virus

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 Mumps Igg Assa.

Pre-market Notification Details

Device IDK923903
510k NumberK923903
Device Name:VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA
ClassificationEnzyme Linked Immunoabsorbent Assay, Mumps Virus
Applicant BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
ContactCheryl Winters-heard
CorrespondentCheryl Winters-heard
BIOMERIEUX VITEK, INC. 595 ANGLUM DR. Hazelwood,  MO  63042 -2395
Product CodeLJY  
CFR Regulation Number866.3380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-08-04
Decision Date1993-08-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03573026064525 K923903 000

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