FDA.reportPublic FDA data

Device Listing 1812779869

Listing Summary#

Listing key
1812779869
Premarket submission
K201675
Device
VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2021-07-09