Device Listing 1809745564

Listing Summary#

Listing key: 1809745564
Premarket submission: K191931
Device: HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)
Applicant: Hardy Diagnostics
Product code: JTN
Decision date: 2019-07-31

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