VIDAS CEA (S) ASSAY— 510(k) K080194

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K080194 for VIDAS CEA (S) ASSAY, Substantially Equivalent on 2008-10-09. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code DHX
Advisory panel: Immunology
Date received: 2008-01-25
Decision date: 2008-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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