FDA 510(k) Applications for Medical Device Product Code "PCH"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K190585 | Applied Biocode, Inc. | Biocode Gastrointestinal Pathogen Panel (GPP) | 06/05/2019 |
| K180041 | Applied Biocode, Inc. | BioCode Gastrointestinal Pathogen Panel (GPP) | 09/28/2018 |
| K242877 | Applied BioCode, Inc. | BioCode Gastrointestinal Pathogen Panel (GPP) | 01/10/2025 |
| K220193 | Becton, Dickinson and Company | BD MAX Enteric Parasite Panel | 08/19/2022 |
| K143648 | BECTON, DICKINSON AND COMPANY | BD MAX Enteric Parasite Panel, BD MAX Instrument | 08/25/2015 |
| K220607 | Becton, Dickinson and Company | BD MAX Enteric Viral Panel | 09/21/2022 |
| K181427 | Becton, Dickinson and Company | BD MAX Enteric Viral Panel, BD MAX Instrument | 11/29/2018 |
| K170308 | BECTON, DICKINSON AND COMPANY | BD MAX Extended Enteric Bacterial Panel, BD MAX System | 05/02/2017 |
| K140407 | Biofire Diagnostics | FILMARRAY GASTROINTESTINAL (GI) PANEL | 05/02/2014 |
| K230404 | BioFire Diagnostics, LLC | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | 03/16/2023 |
| K242367 | BioFire Diagnostics, LLC | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | 11/07/2024 |
| K243885 | BioFire Diagnostics, LLC | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | 01/16/2025 |
| K143005 | BioFire Diagnostics, LLC | FilmArray Gastrointestinal (GI) Panel for use with the FilmArray 2.0 | 02/19/2015 |
| K160459 | BIOFIRE DIAGNOSTICS, LLC | FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch | 04/01/2016 |
| K142501 | CEPHEID | Xpert Norovirus, GeneXpert Dx Systems (GX-I, GX-11, GX-IV, GX-XVI), GeneXpert Infinity-48 System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System | 11/26/2014 |
| K123274 | GEN-PROBE PRODESSE, INC. | PROGASTRO SSCS ASSAY | 01/16/2013 |
| K232672 | Genetic Signatures Limited | EasyScreen Gastrointestinal Parasite Detection Kit | 05/29/2024 |
| K152955 | GREAT BASIN SCIENTIFIC, INC. | Great Basin Shiga Toxin Direct Test | 03/22/2016 |
| K191161 | Luminex Molecular Diagnostics, Inc. | xTAG Gastrointestinal Pathogen Panel (GPP) | 11/12/2019 |
| DEN130003 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) | 01/14/2013 |
| K183023 | Luminex Molecular Diagnostics, Inc. | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | 11/30/2018 |
| K183030 | Luminex Molecular Diagnostics, Inc. | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | 11/30/2018 |
| K191160 | Luminex Molecular Diagnostics, Inc. | xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) | 11/04/2019 |
| K140377 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) | 09/16/2014 |
| K121894 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) LUMINEX MAGPIX | 03/21/2013 |
| K140647 | LUMINEX MOLECULAR DIAGNOSTICS, INC. | XTAG GASTROINTESTINAL PATHOGEN PANEL(GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP(TDAS GPP) | 10/24/2014 |
| K142033 | NANOSPERE,INC. | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST (EP) | 10/10/2014 |
| K140083 | NANOSPHERE, INC | VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP) | 06/20/2014 |
| K220062 | QIAGEN GmbH | QIAstat-Dx Gastrointestinal Panel 2 | 05/31/2024 |
| K250324 | QIAGEN GmbH | QIAstat-Dx GI Panel 2 Mini B | 02/28/2025 |
| K243813 | Qiagen GmbH | QIAstat-Dx GI Panel 2 Mini B&V | 01/08/2025 |
| K182703 | Serosep, Ltd. | EntericBio Dx Assay | 06/19/2019 |
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