Cleared Traditional

VIDAS CEA (S) ASSAY

K080194 · bioMerieux, Inc. · Immunology
Oct 2008
Decision
258d
Days
Class 2
Risk

About This 510(k) Submission

K080194 is an FDA 510(k) clearance for the VIDAS CEA (S) ASSAY, a System, Test, Carcinoembryonic Antigen (Class II — Special Controls, product code DHX), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on October 9, 2008, 258 days after receiving the submission on January 25, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K080194 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2008
Decision Date October 09, 2008
Days to Decision 258 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHX — System, Test, Carcinoembryonic Antigen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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