VIDAS B.R.A.H.M.S. PCT (PCT)— 510(k) K160911

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K160911 for VIDAS B.R.A.H.M.S. PCT (PCT), Substantially Equivalent on 2016-06-28. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code PMT
Device class: Class 2
Regulation: 21 CFR 866.3215
Advisory panel: Microbiology
Date received: 2016-04-01
Decision date: 2016-06-28
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.