K243885
- 510(k) number
- K243885
- Device name
- BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- Applicant
- Biofire Diagnostics, LLC UT · US
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2025-01-16
- Date received
- 2024-12-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243885.pdf
Official FDA record: K243885
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.