Device Listing 1043317367

Listing Summary

Listing key
1043317367
Premarket submission
K242367
Device
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
Applicant
Biofire Diagnostics, LLC
Product code
PCH
Decision date
2024-11-07

Related Registrations

Registration keyRegistrationFEICompanyStatusInitial importerExpirationAddress
17575630027738403002773840BioFire Diagnostics, LLC1N2026-01-01515 Colorow Drive Salt Lake City UT US 84108