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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 a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2022-03-15 under approval 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. It is manufactured by bioMerieux, Inc.. The 510(k) number is K212461.

When was VITEK MS PRIME approved by the FDA?

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

What company makes VITEK MS PRIME?

VITEK MS PRIME is manufactured by bioMerieux, Inc..

What is the FDA product code for VITEK MS PRIME?

The FDA product code for VITEK MS PRIME is QBN.

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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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