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 a medical device manufactured by Biomérieux, Inc.. It received FDA 510(k) clearance on 2022-02-04 under approval 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. It is manufactured by Biomérieux, Inc.. The 510(k) number is K212849.
When was VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) approved by the FDA?
VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) received FDA 510(k) clearance on 2022-02-04, under approval number K212849.
What company makes VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)?
VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL) is manufactured by Biomérieux, Inc..
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.
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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.