Great Basin Stool Bacterial Pathogens Panel
FDA 510(k) clearance K163571 · decided 2017-07-12
Clearance details
- K-number
- K163571
- Device name
- Great Basin Stool Bacterial Pathogens Panel
- Applicant
- Great Basin Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-19
- Decision date
- 2017-07-12
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- PCI
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 (K250358) | Becton, Dickinson and Company | 2025-10-31 |
| BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel (K214122) | Becton, Dickinson and Company | 2022-07-28 |
| PanNAT STEC Test (K173330) | Micronics, Inc. | 2018-06-01 |
| BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT (K140111) | Becton, Dickinson and Company | 2014-05-06 |
Recalls involving this device
No recalls on record reference this clearance.