FDA.reportPublic FDA data

Device Listing 1159861971

Listing Summary#

Listing key
1159861971
Premarket submission
K213931
Device
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2022-06-03