VIDAS CA 125 II ASSAY— 510(k) K080561

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K080561 for VIDAS CA 125 II ASSAY, Substantially Equivalent on 2009-04-10. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code LTK
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2008-02-28
Decision date: 2009-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

Download summary PDF View on FDA.gov ↗

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