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)

Numéro K : K212849 · 2022-02-04

DemandeurBiomérieux, Inc.

Date de décision2022-02-04

Code produitLON

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : LON)

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Source officielle

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