Device Listing 1032034197

Listing Summary#

Listing key: 1032034197
Premarket submission: K260283
Device: VITEK 2 AST-Streptococcus Meropenem (=0.06 - =4 µg/mL)
Applicant: bioMerieux, Inc.
Product code: LON
Decision date: 2026-10-01

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