K260281
- 510(k) number
- K260281
- Device name
- VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
- Applicant
- BIOMERIEUX MO · US
- Product code
- LON — System, Test, Automated, Antimicrobial Susceptibilit
- Decision date
- 2026-03-26
- Date received
- 2026-01-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K260281.pdf
Official FDA record: K260281
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.