BIOFIRE FILMARRAY Gastrointestinal (GI) Panel— 510(k) K242367

Name: FDA 510(k) clearance K242367
Creator: U.S. Food and Drug Administration
Published: 2024-11-07

Substantially Equivalent

Biofire Diagnostics, LLC

FDA 510(k) clearance K242367 for BIOFIRE FILMARRAY Gastrointestinal (GI) Panel, Substantially Equivalent on 2024-11-07. Applicant: Biofire Diagnostics, LLC. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics, LLC
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2024-08-09
Decision date: 2024-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PCH

view all

K253722 — LIAISON PLEX Gastrointestinal Flex Assay2026-05-19
K254032 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2026-03-09
K251721 — Xpert GI Panel2026-01-16
K252329 — QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V2025-10-22
K251868 — Panther Fusion GI Bacterial Assay2025-09-25

More clearances from Biofire Diagnostics, LLC

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.