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FDA 510(k)

VITEK MS PRIME

K-Number: K212461 · 2022-03-15

ApplicantbioMerieux, Inc.
Decision Date2022-03-15
Product CodeQBN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK MS PRIME is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2022-03-15 under 510(k) number K212461. The device is classified under product code QBN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK MS PRIME?

VITEK MS PRIME is a medical device that received FDA 510(k) clearance on 2022-03-15. The listed applicant is bioMerieux, Inc.. The 510(k) number is K212461.

When did VITEK MS PRIME receive FDA 510(k) clearance?

VITEK MS PRIME received FDA 510(k) clearance on 2022-03-15, under 510(k) number K212461.

Who is the listed applicant for VITEK MS PRIME?

The FDA 510(k) record lists bioMerieux, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITEK MS PRIME?

The FDA product code for VITEK MS PRIME is QBN.

Other records listing bioMerieux, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QBN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251495MBT Compass HT CA Software; MBT FAST Shuttle US IVDBruker Daltonics GmbH & Co. KGK181412VITEK MSbioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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