VITEK MS PRIME— 510(k) K212461

Substantially Equivalent

bioMerieux, Inc.

FDA 510(k) clearance K212461 for VITEK MS PRIME, Substantially Equivalent on 2022-03-15. Applicant: bioMerieux, Inc.. Device class: 2.

Clearance details

Applicant: bioMerieux, Inc.
Product code: Code QBN
Device class: Class 2
Regulation: 21 CFR 866.3378
Advisory panel: Microbiology
Date received: 2021-08-06
Decision date: 2022-03-15
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.