FDA 510(k) Applications for Medical Device Product Code "PEN"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K130914 | BIOFIRE DIAGNOSTICS, INC. | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | 06/21/2013 |
| K193519 | BioFire Diagnostics, LLC | BioFire Blood Culture Identification 2 (BCID2) Panel | 03/18/2020 |
| K243759 | BioFire Diagnostics, LLC | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | 12/20/2024 |
| K181493 | BioFire Diagnostics, LLC | FilmArray Blood Culture Identification (BCID) Panel | 07/05/2018 |
| K160457 | BIOFIRE DIAGNOSTICS, LLC | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | 03/15/2016 |
| K143171 | Biofire Diagnostics, LLC. | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | 01/30/2015 |
| K182619 | GenMark Diagnostics, Incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | 04/12/2019 |
| K213236 | GenMark Diagnostics, Incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | 04/27/2022 |
| K190341 | iCubate, Inc. | iC-GN iC-Cassette for use on the iC-System | 06/28/2019 |
| K243013 | Luminex Corporation | LIAISON PLEX Gram-Negative Blood Culture Assay | 04/18/2025 |
| K132843 | NANOSPHERE, INC | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | 01/08/2014 |
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