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FDA 510(k)

VITEK MS

K-Number: K162950 · 2017-07-22

ApplicantbioMerieux, Inc.
Decision Date2017-07-22
Product CodePEX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK MS is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-07-22 under approval number K162950. The device is classified under product code PEX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK MS?

VITEK MS is a medical device that received FDA 510(k) clearance on 2017-07-22. It is manufactured by bioMerieux, Inc.. The 510(k) number is K162950.

When was VITEK MS approved by the FDA?

VITEK MS received FDA 510(k) clearance on 2017-07-22, under approval number K162950.

What company makes VITEK MS?

VITEK MS is manufactured by bioMerieux, Inc..

What is the FDA product code for VITEK MS?

The FDA product code for VITEK MS is PEX.

Other Devices by bioMerieux, Inc.

K162076chromID MRSA K161227VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) K160911VIDAS B.R.A.H.M.S. PCT (PCT) K152075VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) K151923VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) K151688chromID MRSA

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Related Devices (Code: PEX)

K163536MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH

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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