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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 the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2018-12-21 under 510(k) 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. The listed applicant is bioMerieux, Inc.. The 510(k) number is K181412.

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

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

Who is the listed applicant for VITEK MS?

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?

The FDA product code for VITEK MS 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.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST SystemK260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceK260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PROK232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

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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. KGK212461VITEK MS PRIMEbioMerieux, 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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