510(k) K242367 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, Nov 7, 2024 |
| Received | Aug 9, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242367
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.