510(k) DEN170045
DEN170045 is an FDA 510(k) premarket notification submitted by Banyan Biomarkers, Inc. for the device "Banyan BTI". The FDA issued a decision of De Novo Granted on February 14, 2018. The device falls under product code QAT (Brain Trauma Assessment Test), a Class II device regulated under 21 CFR 866.5830.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- February 14, 2018
- Date Received
- August 28, 2017
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brain Trauma Assessment Test
- Device Class
- Class II
- Regulation Number
- 866.5830
- Review Panel
- IM
- Submission Type
Intended for in vitro diagnostic use as an aid in the evaluation of patients with suspected mild traumatic brain injury (TBI) in conjunction with other clinical information to assist in determining the need for radiologic (e.g., CT, MR) head imaging per current standard of care