Cleared Traditional

VIDAS CMV IGG ASSAY

K920661 · Vitek Systems, Inc. · Microbiology
Feb 1993
Decision
365d
Days
Class 2
Risk

About This 510(k) Submission

K920661 is an FDA 510(k) clearance for the VIDAS CMV IGG ASSAY, a Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (Class II — Special Controls, product code LFZ), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on February 12, 1993, 365 days after receiving the submission on February 13, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K920661 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 1992
Decision Date February 12, 1993
Days to Decision 365 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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