510(k) K231348
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 2023
- Date Received
- May 9, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- AlzheimerS Disease Pathology Assessment Test
- Device Class
- Class II
- Regulation Number
- 866.5840
- Review Panel
- IM
- Submission Type
In vitro test to determine whether a patient presenting with cognitive impairment and being evaluated for AD and other causes of cognitive decline will test positive or negative for amyloid plaques or neurofibrillary tangles as measured by PET imaging agents.