Device Listing 1563916653

Listing Summary#

Listing key: 1563916653
Premarket submission: K260619
Device: VITEK 2 AST-Streptococcus Cefepime (<=0.06 – >=4 µg/mL)
Applicant: Biomérieux, Inc.
Product code: LON
Decision date: 2026-09-28

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
9759	1950204	1950204	BIOMERIEUX, INC.	1	Y	2027-01-01	595 ANGLUM RD. HAZELWOOD MO US 63042