510(k) K243222 · QDS Mers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System
BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)
| Applicant | Biofire Diagnostics, LLC (Biomerieux), Salt Lake City UT, US |
| Decision | Substantially Equivalent, Nov 6, 2024 |
| Received | Oct 7, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K243222
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 13, 2026 | BioFire Diagnostics, LLC 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 k Open, Classified |
QDP | None listed |
| Oct 13, 2026 | BioFire Diagnostics, LLC 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: Open, Classified |
QDS | None listed |
| Apr 4, 2025 | BioFire Diagnostics, LLC FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Open, Classified |
QDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.