VIDAS AFP ASSAY— 510(k) K080017

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K080017 for VIDAS AFP ASSAY, Substantially Equivalent on 2008-09-26. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LOJ
Advisory panel: Immunology
Date received: 2008-01-03
Decision date: 2008-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.