FDA.reportPublic FDA data

Device Listing 1004959614

Listing Summary#

Listing key
1004959614
Premarket submission
K191766
Device
VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2019-08-05