Device Listing 1130190516

Listing Summary#

Listing key: 1130190516
Premarket submission: K160459
Device: FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch
Applicant: Biofire Diagnostics, LLC
Product code: PCH
Decision date: 2016-04-01

Registration key, Registration, FEI table
Registration key	Registration	FEI	Company	Status	Initial importer	Expiration	Address
175756	3002773840	3002773840	BioFire Diagnostics, LLC	1	N	2026-01-01	515 Colorow Drive Salt Lake City UT US 84108