Cleared Traditional

VIDAS AFP ASSAY

K080017 · bioMerieux, Inc. · Immunology
Sep 2008
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K080017 is an FDA 510(k) clearance for the VIDAS AFP ASSAY, a Kit, Test,alpha-fetoprotein For Testicular Cancer (Class II — Special Controls, product code LOJ), submitted by bioMerieux, Inc. (Hazelwood, US). The FDA issued a Cleared decision on September 26, 2008, 267 days after receiving the submission on January 3, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K080017 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2008
Decision Date September 26, 2008
Days to Decision 267 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LOJ — Kit, Test,alpha-fetoprotein For Testicular Cancer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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