Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA

K923903 · Biomerieux Vitek, Inc. · Microbiology
Aug 1993
Decision
370d
Days
Class 1
Risk

About This 510(k) Submission

K923903 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA, a Enzyme Linked Immunoabsorbent Assay, Mumps Virus (Class I — General Controls, product code LJY), submitted by Biomerieux Vitek, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 9, 1993, 370 days after receiving the submission on August 4, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3380.

Submission Details

510(k) Number K923903 FDA.gov
FDA Decision Cleared SESE
Date Received August 04, 1992
Decision Date August 09, 1993
Days to Decision 370 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJY — Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3380

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