510(k) K223602
K223602 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "Traumatic brain injury (TBI) test". The FDA issued a decision of Substantially Equivalent on March 2, 2023. The device falls under product code QAT (Brain Trauma Assessment Test), a Class II device regulated under 21 CFR 866.5830. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 2, 2023
- Date Received
- December 2, 2022
- Clearance Type
- Traditional
- 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