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Company-Registration
1872557390
Device Listing 1872557390
Listing Summary
#
Listing key
1872557390
Premarket submission
K260842
Device
HardyDisk AST Gepotidacin 10µg (GEP10)
Applicant
Hardy Diagnostics
Product code
JTN
Decision date
2026-05-11
Related Registrations
#
Registration key, Registration, FEI table
Registration key
Registration
FEI
Company
Status
Initial importer
Expiration
Address
34263
2022807
2022807
HARDY DIAGNOSTICS
1
Y
2026-01-01
1430 WEST MCCOY LN. Orcutt CA US 93455