510(k) K152955
- Device
- Great Basin Shiga Toxin Direct Test
- Applicant
- GREAT BASIN SCIENTIFIC, INC.
- 510(k) number
- K152955
- Product code
- PCH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-03-22
- Date received
- 2015-10-07
- Regulation
- 866.3990
- Classification name
- Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chuck Owen
- Address
- 2441 S. 3850 W. Salt Lake City UT US 84120 84120
FDA Registration Numbers#
- 2024800
- 3005360469
- 1119779
- 3007420875
- 3010749841
- 3002777243
- 3004530258
- 3007799234
- 3014553740
- 3011781554
- 3016838963
- 3004013603
- 1650733
- 3009613136
- 3002773840
- 3006028115
Source Documents#
Other 510(k) Records For Product Code PCH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253722 | LIAISON PLEX Gastrointestinal Flex Assay | Luminex Corporation | 2026-05-19 |
| K254032 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2026-03-09 |
| K251721 | Xpert GI Panel | Cepheid | 2026-01-16 |
| K252329 | QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025-10-22 |
| K251993 | Panther Fusion GI Expanded Bacterial Assay | Hologic, Inc. | 2025-09-25 |
| K251868 | Panther Fusion GI Bacterial Assay | Hologic | 2025-09-25 |
| K250324 | QIAstat-Dx GI Panel 2 Mini B | QIAGEN GmbH | 2025-02-28 |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid | Biofire Diagnostics, LLC | 2025-01-16 |
| K242877 | BioCode Gastrointestinal Pathogen Panel (GPP) | Applied BioCode, Inc. | 2025-01-10 |
| K243813 | QIAstat-Dx GI Panel 2 Mini B&V | QIAGEN GmbH | 2025-01-08 |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024-11-07 |
| K220062 | QIAstat-Dx Gastrointestinal Panel 2 | QIAGEN GmbH | 2024-05-31 |
| K232672 | EasyScreen Gastrointestinal Parasite Detection Kit | Genetic Signatures Limited | 2024-05-29 |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2023-03-16 |
| K220607 | BD MAX Enteric Viral Panel | Becton, Dickinson and Company | 2022-09-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary