510(k) K163571
- Device
- Great Basin Stool Bacterial Pathogens Panel
- Applicant
- Great Basin Scientific, Inc.
- 510(k) number
- K163571
- Product code
- PCI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-07-12
- Date received
- 2016-12-19
- Regulation
- 866.3990
- Classification name
- Gastrointestinal Bacterial 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
- Suzette Chance
- Address
- 2441 S. 3850 W. Salt Lake City UT US 84120 84120
FDA Registration Numbers#
- 1119779
- 3007420875
- 3006028115
Source Documents#
Other 510(k) Records For Product Code PCI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System | Becton, Dickinson and Company | 2025-10-31 |
| K214122 | BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel | Becton, Dickinson and Company | 2022-07-28 |
| K173330 | PanNAT STEC Test | Micronics, Inc. | 2018-06-01 |
| K140111 | BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT | Becton, Dickinson and Company | 2014-05-06 |
Legacy Summary#
summary
FDA Review#
Decision Summary