Banyan BTI
FDA 510(k) clearance DEN170045 · decided 2018-02-14
Clearance details
- K-number
- DEN170045
- Device name
- Banyan BTI
- Applicant
- Banyan Biomarkers, Inc.
- Decision
- Unknown
- Date received
- 2017-08-28
- Decision date
- 2018-02-14
- Days to decision
- 170 days
- Clearance type
- Direct
- Product code
- QAT
- Device class
- 2
- Regulation number
- 866.5830
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Banyan Biomarkers
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VIDAS TBI (GFAP, UCH-L1) (K240279) | bioMerieux, Inc. | 2024-05-01 |
| i-STAT TBI Cartridge with the i-STAT Alinity System (K234143) | Abbott Point of Care | 2024-03-27 |
| TBI (K232669) | Abbott Laboratories | 2023-09-29 |
| Traumatic brain injury (TBI) test (K223602) | Abbott Laboratories | 2023-03-02 |
| i-STAT TBI Plasma cartridge with the i-STAT Alinity System (K201778) | Abbott Laboratories | 2021-01-08 |
Recalls involving this device
No recalls on record reference this clearance.