Device Listing 1355881271

Listing Summary#

Listing key: 1355881271
Premarket submission: K250274
Device: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
Applicant: Biomerieux S.A.
Product code: JWY
Decision date: 2025-04-30

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