Device Listing 1951517469

Listing Summary#

Listing key: 1951517469
Premarket submission: K193572
Device: VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)
Applicant: bioMerieux, Inc.
Product code: LON
Decision date: 2020-03-13

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
330867	3031977134	3031977134	bioMerieux, Inc.	1	N	2026-01-01	3015 Carrington Mill Blvd Morrisville NC US 27560