FDA.reportPublic FDA data

Device Listing 1428133906

Listing Summary#

Listing key
1428133906
Premarket submission
K234000
Device
VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2024-03-11