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)

Numéro K : K260281 · 2026-03-26

DemandeurBIOMERIEUX

Date de décision2026-03-26

Code produitLON

Comité consultatifMI

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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Dispositifs connexes (Code : LON)

K260282VITEK 2 AST-Streptococcus Inducible Clindamycin ResistancebioMerieux, Inc.K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)bioMerieux, Inc.K251713BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)Becton, Dickinson and Company K250447BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)Becton, Dickinson and Company K234012VITEK COMPACT PRObioMerieux, Inc.K250344BD Phoenix™ Automated Microbiology SystemBecton, Dickinson and Company

Source officielle

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