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FDA 510(k)

VITEK MS

K-Number: K181412 · 2018-12-21

ApplicantbioMerieux, Inc.
Decision Date2018-12-21
Product CodeQBN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VITEK MS is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2018-12-21 under approval number K181412. 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?

VITEK MS is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by bioMerieux, Inc.. The 510(k) number is K181412.

When was VITEK MS approved by the FDA?

VITEK MS received FDA 510(k) clearance on 2018-12-21, under approval number K181412.

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 QBN.

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: QBN)

DEN170081MALDI Biotyper CA SystemBruker Daltonik GmbH K212461VITEK MS PRIMEbioMerieux, Inc. K251495MBT Compass HT CA Software; MBT FAST Shuttle US IVDBruker Daltonics GmbH & Co. KG

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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