510(k) clearance
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
- 510(k) number
- K260619
- Applicant
- Biomérieux, Inc.
- Decision date
- Sep 28, 2026
- Date received
- Feb 25, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LON
- Device type
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II
- Regulation
- 21 CFR 866.1645
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Hazelwood, MO, US