FDA 510(k)

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance

K-Number: K260282 · 2026-04-15

Decision Date2026-04-15

Product CodeLON

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance is the device name listed in this FDA 510(k) record. The listed applicant is bioMerieux, Inc.. It received FDA 510(k) clearance on 2026-04-15 under 510(k) number K260282. 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-Streptococcus Inducible Clindamycin Resistance?

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance is a medical device that received FDA 510(k) clearance on 2026-04-15. The listed applicant is bioMerieux, Inc.. The 510(k) number is K260282.

When did VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance receive FDA 510(k) clearance?

VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance received FDA 510(k) clearance on 2026-04-15, under 510(k) number K260282.

Who is the listed applicant for VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance?

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

What is the FDA product code for VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance?

The FDA product code for VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance is LON.

Other records listing bioMerieux, 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.

K260160VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)K251579VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)K234012VITEK COMPACT PRO K232967VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)K232963VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

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Related Devices (Code: LON)

K260281VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)BIOMERIEUX 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

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.