FDA.reportPublic FDA data

Device Listing 1455922687

Listing Summary#

Listing key
1455922687
Premarket submission
K161437
Device
VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2017-02-16