Cleared Traditional

VIDAS CMV IGM ASSAY

K933549 · Biomerieux Vitek, Inc. · Microbiology
Aug 1994
Decision
376d
Days
Class 2
Risk

About This 510(k) Submission

K933549 is an FDA 510(k) clearance for the VIDAS CMV IGM ASSAY, a Antibody Igm,if, Cytomegalovirus Virus (Class II — Special Controls, product code LKQ), submitted by Biomerieux Vitek, Inc. (Rockland, US). The FDA issued a Cleared decision on August 2, 1994, 376 days after receiving the submission on July 22, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K933549 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1993
Decision Date August 02, 1994
Days to Decision 376 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LKQ — Antibody Igm,if, Cytomegalovirus Virus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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