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
1290214745
Device Listing 1290214745
Listing Summary
#
Listing key
1290214745
Premarket submission
K192326
Device
HardyDisk AST Lefamulin 20µg (LMU20)
Applicant
Hardy Diagnostics
Product code
JTN
Decision date
2019-09-19
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
40474
8020667
4247
MAST GROUP LTD.
1
N
2026-01-01
MAST HOUSE, DERBY RD. BOOTLE, MERSEYSIDE Liverpool GB L20 1EA