BIOFIRE SPOTFIRE Vaginitis (VG) Panel— 510(k) K262136
Substantially EquivalentBiofire Diagnostics, LLC
FDA 510(k) clearance K262136 for BIOFIRE SPOTFIRE Vaginitis (VG) Panel, Substantially Equivalent on 2026-10-21. Applicant: Biofire Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- Biofire Diagnostics, LLC
- Product code
- Product code PQA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3975
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Location
- Salt Lake City, UT, US
Recent devices under product code PQA
view allMore clearances from Biofire Diagnostics, LLC
view all- K243544 — BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini
- K243885 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid
- K243759 — BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- K242367 — BIOFIRE FILMARRAY Gastrointestinal (GI) Panel
- K241194 — BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini
Data sourced from openFDA. This site is unofficial and independent of the FDA.