BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more— 510(k) K243222
Substantially EquivalentBiofire Diagnostics, LLC (Biomerieux)
FDA 510(k) clearance K243222 for BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) +1 more, Substantially Equivalent on 2024-11-06. Applicant: Biofire Diagnostics, LLC (Biomerieux). Device class: 2.
Clearance details
- Device name as filed
- BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
- Applicant
- Biofire Diagnostics, LLC (Biomerieux)
- Product code
- Product code QDS
- Device class
- Class 2
- Regulation
- 21 CFR 866.4001
- Advisory panel
- Pathology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Salt Lake City, UT, US
Recent devices under product code QDS
view allMore clearances from Biofire Diagnostics, LLC (Biomerieux)
view allAdverse events under product code QDS
product code QDS- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K243222
K-number listed on FDA's recall record- Z-0149-2027 — Generic Name: FilmArray¿ Pneumonia Panel plus Generic Name: FilmArray¿ Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFIT-ASY-0142 (6 Kit) Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Z-0148-2027 — Generic Name: FilmArray¿ Pneumonia Panel Generic Name: FilmArray¿ Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-0145 (6 pack), FLM1-ASY-0150 (Verification Kits). Verification kit lots (FLM1-ASY-0150) are a sales configuration that consume kits from panel lots (RFIT-ASY-0144). Software Version: N/A Product Description: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) Component: N/A
- Z-1518-2025 — FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K243222.
Data sourced from openFDA. This site is unofficial and independent of the FDA.