FDA 510(k) Applications Submitted by BIOFIRE DIAGNOSTICS, LLC
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K230404 |
02/15/2023 |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel |
BioFire Diagnostics, LLC |
| K230719 |
03/15/2023 |
BIOFIRE« SPOTFIRE« Respiratory (R) Panel Mini |
Biofire Diagnostics, LLC |
| K212727 |
08/27/2021 |
FilmArray Pneumonia Panel |
BioFire Diagnostics, LLC |
| K222601 |
08/29/2022 |
FilmArray Pneumonia Panel plus |
BioFire Diagnostics, LLC |
| DEN200066 |
10/27/2020 |
BioFire Joint Infection (JI) Panel |
BioFire Diagnostics, LLC |
| K143005 |
10/20/2014 |
FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 |
BioFire Diagnostics, LLC |
| K143080 |
10/27/2014 |
FilmArray Respiratory Panel (RP) for use with Multi-instrument FilmArray System |
BioFire Diagnostics, LLC |
| K193519 |
12/19/2019 |
BioFire Blood Culture Identification 2 (BCID2) Panel |
BioFire Diagnostics, LLC |
| K143178 |
11/04/2014 |
FilmArray 2.0 System |
BioFire Diagnostics, LLC |
| DEN150013 |
04/09/2015 |
FilmArray Meningitis/Encephalitis(ME) Panel |
BioFire Diagnostics, LLC |
| DEN200031 |
05/19/2020 |
BioFire Respiratory Panel 2.1 (RP2.1) |
Biofire Diagnostics, LLC |
| K160068 |
01/13/2016 |
FilmArray Respiratory Panel (RP) for use with FilmArray Torch |
BioFire Diagnostics, LLC |
| K160457 |
02/19/2016 |
FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch |
BIOFIRE DIAGNOSTICS, LLC |
| K160459 |
02/19/2016 |
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch |
BIOFIRE DIAGNOSTICS, LLC |
| K160462 |
02/19/2016 |
FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch |
BIOFIRE DIAGNOSTICS, LLC |
| K170604 |
03/01/2017 |
FilmArray Respiratory Panel 2 (RP2) |
BioFire Diagnostics, LLC |
| DEN170017 |
03/16/2017 |
FilmArray Respiratory Panel 2 plus (RP2plus) |
BioFire Diagnostics, LLC |
| K180966 |
04/13/2018 |
FilmArray Pneumonia Panel |
BioFire Diagnostics, LLC |
| K181324 |
05/18/2018 |
FilmArray Pneumonia Panel plus |
BioFire Diagnostics, LLC |
| K181493 |
06/06/2018 |
FilmArray Blood Culture Identification (BCID) Panel |
BioFire Diagnostics, LLC |
| K152579 |
09/10/2015 |
FilmArray Respiratory Panel EZ (RP EZ) |
BIOFIRE DIAGNOSTICS, LLC |
|
|
