Device type
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Product code LON · Class II · 21 CFR 866.1645 · Microbiology
Recent 510(k)s
Oct 1, 2026
K260283
VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
bioMerieux, Inc.
- LON
- Class II
Sep 28, 2026
K260619
VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
Biomérieux, Inc.
- LON
- Class II
Recent recalls
Oct 21, 2026
Z-0139-2027
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Becton Dickinson & Co.
- LON
- Class II
- Ongoing
Oct 21, 2026
Z-0140-2027
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Becton Dickinson & Co.
- LON
- Class II
- Ongoing
Sep 30, 2026
Z-3231-2026
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
Biomerieux Inc
- LON
- Class II
- Ongoing