Skip to content
FDA.report
Public FDA data
NDC
RxNorm
DailyMed
Applications
GUDID
GMDN
PMA
PMN
MAUDE
Recalls
Search FDA.report
Search
Home
Company-Registration
1029844055
Device Listing 1029844055
Listing Summary
#
Listing key
1029844055
Premarket submission
K172731
Device
VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
Applicant
bioMerieux, Inc.
Product code
LON
Decision date
2017-12-08
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9759
1950204
1950204
BIOMERIEUX, INC.
1
Y
2026-01-01
595 ANGLUM RD. HAZELWOOD MO US 63042
330867
3031977134
3031977134
bioMerieux, Inc.
1
N
2026-01-01
3015 Carrington Mill Blvd Morrisville NC US 27560