510(k) DEN170045
- Device
- Banyan BTI
- Applicant
- Banyan Biomarkers, Inc.
- 510(k) number
- DEN170045
- Product code
- QAT
- Decision
- Unknown (DENG)
- Decision date
- 2018-02-14
- Date received
- 2017-08-28
- Regulation
- 866.5830
- Classification name
- Brain Trauma Assessment Test
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Steven P. Richieri
- Address
- 16470 W. Bernardo Dr. Suite 100 San Diego CA US 92127 92127
FDA Registration Numbers#
- 3002809144
- 3005643513
- 2032839
- 8020790
- 3008344661
- 2245578
- 2953756
- 3005333358
- 2085064
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QAT#
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|---|---|---|---|
| K240279 | VIDAS TBI (GFAP, UCH-L1) | bioMerieux, Inc. | 2024-05-01 |
| K234143 | i-STAT TBI Cartridge with the i-STAT Alinity System | Abbott Point of Care | 2024-03-27 |
| K232669 | TBI | Abbott Laboratories | 2023-09-29 |
| K223602 | Traumatic brain injury (TBI) test | Abbott Laboratories | 2023-03-02 |
| K201778 | i-STAT TBI Plasma cartridge with the i-STAT Alinity System | Abbott Laboratories | 2021-01-08 |