Biofire Diagnostics, LLC
FDA 510(k) & PMA Approved Devices — 20 products
Total Devices20
Categories7
Latest FDA decision2025-08-14
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini | QOF | 2025-08-14 | View |
| 510(k) | K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | PCH | 2025-01-16 | View |
| 510(k) | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | PEN | 2024-12-20 | View |
| 510(k) | K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | 2024-11-07 | View |
| 510(k) | K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini | QOF | 2024-05-30 | View |
| 510(k) | K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel | QOF | 2024-03-26 | View |
| 510(k) | K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini | QOF | 2023-04-13 | View |
| 510(k) | K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | PCH | 2023-03-16 | View |
| 510(k) | K222601 | FilmArray Pneumonia Panel plus | QDS | 2022-10-27 | View |
| 510(k) | K212727 | FilmArray Pneumonia Panel | QDP | 2021-09-22 | View |
| 510(k) | K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | PEN | 2020-03-18 | View |
| 510(k) | K181324 | FilmArray Pneumonia Panel plus | QDS | 2018-11-15 | View |
| 510(k) | K180966 | FilmArray Pneumonia Panel | QDP | 2018-11-09 | View |
| 510(k) | K181493 | FilmArray Blood Culture Identification (BCID) Panel | PEN | 2018-07-05 | View |
| 510(k) | K170604 | FilmArray Respiratory Panel 2 (RP2) | OCC | 2017-05-30 | View |
| 510(k) | K152579 | FilmArray Respiratory Panel EZ (RP EZ) | OCC | 2016-10-03 | View |
| 510(k) | K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | PCH | 2016-04-01 | View |
| 510(k) | K160462 | FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch | PLO | 2016-03-17 | View |
| 510(k) | K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | PEN | 2016-03-15 | View |
| 510(k) | K160068 | FilmArray Respiratory Panel (RP) for use with FilmArray Torch | OCC | 2016-02-08 | View |
No matching devices.