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
1339031084
Device Listing 1339031084
Listing Summary
#
Listing key
1339031084
Premarket submission
K191953
Device
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
Applicant
Biomerieux S.A.
Product code
JWY
Decision date
2019-08-22
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
9762
9615754
3008237827
Nathan Hardesty
1
N
2026-01-01
595 Anglum Rd Bldg. 1, 2nd Flr. Hazelwood MO US 63042