510(k) K230404 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 16, 2023 |
| Received | Feb 15, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K230404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2024 | BioFire Diagnostics, LLC 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 Open, Classified |
PCH | None listed |
| Feb 15, 2024 | BioFire Diagnostics, LLC 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. Open, Classified |
PCH | None listed |
| Jan 10, 2024 | BioFire Diagnostics, LLC BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems. Open, Classified |
PCH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.