When did VITEK 2 AST-Streptococcus Cefuroxime ( =8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Streptococcus Cefuroxime ( =8 µg/mL) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K260281.

FDA 510(k)

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)

Número K: K260281 · 2026-03-26

RequerenteBIOMERIEUX

Data da decisão2026-03-26

Código do produtoLON

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) is the device name listed in this FDA 510(k) record. The listed applicant is BIOMERIEUX. It received FDA 510(k) clearance on 2026-03-26 under 510(k) number K260281. The device is classified under product code LON. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)?

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) is a medical device that received FDA 510(k) clearance on 2026-03-26. The listed applicant is BIOMERIEUX. The 510(k) number is K260281.

When did VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) receive FDA 510(k) clearance?

VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) received FDA 510(k) clearance on 2026-03-26, under 510(k) number K260281.

Who is the listed applicant for VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)?

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

What is the FDA product code for VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)?

The FDA product code for VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) is LON.

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