When did VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Positive Linezolid ( =8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212849.

FDA 510(k)

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)

K-Number: K212849 · 2022-02-04

ApplicantBiomérieux, Inc.

Decision Date2022-02-04

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is Biomérieux, Inc.. It received FDA 510(k) clearance on 2022-02-04 under 510(k) number K212849. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is a medical device that received FDA 510(k) clearance on 2022-02-04. The listed applicant is Biomérieux, Inc.. The 510(k) number is K212849.

When did VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under 510(k) number K212849.

Who is the listed applicant for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL)?

The FDA product code for VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) is LON.

Other records listing Biomérieux, 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: LON)

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Official Source

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