510(k) clearance
BIOFIRE Respiratory Panel 2.1 (RP2.1)
- 510(k) number
- K263054
- Applicant
- Biofire Diagnostics
- Decision date
- Sep 22, 2026
- Date received
- Sep 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QOF
- Device type
- Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
- Device class
- Class II
- Regulation
- 21 CFR 866.3981
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Salt Lake City, UT, US