FDA.reportPublic FDA data

Device Listing 1118608189

Listing Summary#

Listing key
1118608189
Premarket submission
K210287
Device
VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2021-10-28