510(k) clearance
BIOFIRE SPOTFIRE Vaginitis (VG) Panel
- 510(k) number
- K262136
- Applicant
- Biofire Diagnostics, LLC
- Decision date
- Oct 21, 2026
- Date received
- Jun 25, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Product code
- PQA
- Device type
- Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
- Device class
- Class II
- Regulation
- 21 CFR 866.3975
- Advisory committee
- Microbiology
- Statement or summary
- Summary
- Third party
- N
- Location
- Salt Lake City, UT, US