VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)— 510(k) K260281
Substantially EquivalentBIOMERIEUX
FDA 510(k) clearance K260281 for VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), Substantially Equivalent on 2026-03-26. Applicant: BIOMERIEUX. Device class: 2.
Summary
BIOMERIEUX's VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) is filed under LON, short-incubation automated antimicrobial susceptibility test systems. The record doesn't describe the product beyond its name and that code name.
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. Review took 56 calendar days (January 29 to March 26, 2026).
Clearance details
- Applicant
- BIOMERIEUX
- 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)
- K260282 — VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance
- 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
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.