FDA 510(k) Applications Submitted by Kristen J Kanack
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K250324 |
02/05/2025 |
QIAstat-Dx GI Panel 2 Mini B |
QIAGEN GmbH |
| 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 |
| K143171 |
11/04/2014 |
FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 |
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 |
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