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510(k) K232669

TBI by Abbott Laboratories — Product Code QAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2023
Date Received
September 1, 2023
Clearance Type
Special
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

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