VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance— 510(k) K260282
Substantially EquivalentbioMerieux, Inc.
FDA 510(k) clearance K260282 for VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance, Substantially Equivalent on 2026-04-15. Applicant: bioMerieux, Inc.. Device class: 2.
Summary
bioMerieux's VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance is filed under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation).
Class II, 21 CFR 866.1645. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
bioMerieux filed from Hazelwood, Missouri. The decision came 76 calendar days after FDA received it (January 29 to April 15, 2026).
Clearance details
- Applicant
- bioMerieux, Inc.
- Product code
- Product code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hazelwood, MO, US
Recent devices under product code LON
view all- K260283 — VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
- K260619 — VITEK 2 AST-Streptococcus Cefepime (<=0.06 >=4 µg/mL)
- K260281 — VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- K251579 — VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)
- K251713 — BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)
More clearances from bioMerieux, Inc.
view allAdverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.