Cleared Traditional

VIDAS RUB IGG

K080766 · bioMerieux, Inc. · Microbiology
Dec 2008
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K080766 is an FDA 510(k) clearance for the VIDAS RUB IGG, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on December 23, 2008, 280 days after receiving the submission on March 18, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K080766 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2008
Decision Date December 23, 2008
Days to Decision 280 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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