FILMARRAY GASTROINTESTINAL (GI) PANEL— 510(k) K140407

Name: FDA 510(k) clearance K140407
Creator: U.S. Food and Drug Administration
Published: 2014-05-02

Substantially Equivalent

Biofire Diagnostics

FDA 510(k) clearance K140407 for FILMARRAY GASTROINTESTINAL (GI) PANEL, Substantially Equivalent on 2014-05-02. Applicant: Biofire Diagnostics. Device class: 2.

Clearance details

Applicant: Biofire Diagnostics
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2014-02-18
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K140407

K-number listed on FDA's recall record

Z-2514-2024 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0104 (6 kit test) The BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE¿ FILMARRAY¿ Systems. The BIOFIRE GI Panel is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites directly from stool samples in Cary Blair transport media obtained from individuals with signs and/or symptoms of gastrointestinal infection.Class II·Ongoing·BioFire Diagnostics, LLC·20240516
Z-1140-2024 — FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex nucleic acid-based assay. In vitro diagnostic.Class II·Ongoing·BioFire Diagnostics, LLC·20240126
Z-0703-2024 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.Class II·Ongoing·BioFire Diagnostics, LLC·20231127
Z-2588-2023 — FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module SoftwareClass II·Ongoing·BioFire Diagnostics, LLC·20230425
Z-1392-2023 — FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit)Class II·Ongoing·BioFire Diagnostics, LLC·20230308
Z-1253-2023 — In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116Class II·Ongoing·BioFire Diagnostics, LLC·20230201
Z-1451-2020 — FilmArray Gastronintestinal (GI) Panel, REF: RFIT-ASY-0104, 6-pack kit, UDI (01)00815381020116, CE IVD, Rx OnlyClass II·Terminated·BioFire Diagnostics, LLC·20190808
Z-1242-2019 — FilmArray Gastrointestinal (GI) Panel, IVD, Rx Only, Biofire Diagnostics, LLC REF: RFIT-ASY-0104, and RFIT-ASY-0116), Product Usage: The FilmArray Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.Class II·Terminated·BioFire Diagnostics, LLC·20190306

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140407.

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