510(k) K243885 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
| Applicant | Biofire Diagnostics, LLC, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Jan 16, 2025 |
| Received | Dec 18, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243885
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.