Device Listing 1673548259

Listing Summary#

Listing key: 1673548259
Premarket submission: K260281
Device: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
Applicant: BIOMERIEUX
Product code: LON
Decision date: 2026-03-26

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
9759	1950204	1950204	BIOMERIEUX, INC.	1	Y	2026-01-01	595 ANGLUM RD. HAZELWOOD MO US 63042