VIDAS B.R.A.H.M.S. PCT ASSAY— 510(k) K071146

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K071146 for VIDAS B.R.A.H.M.S. PCT ASSAY, Substantially Equivalent on 2007-10-11. Applicant: bioMerieux, Inc..

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code NTM
Advisory panel: Microbiology
Date received: 2007-04-24
Decision date: 2007-10-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MO, US

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