FDA.reportPublic FDA data

Device Listing 1453194829

Listing Summary#

Listing key
1453194829
Premarket submission
K193567
Device
VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2020-02-14