510(k) K243891
K243891 is an FDA 510(k) premarket notification submitted by Earlitec Diagnostics for the device "EarliPoint System". The FDA issued a decision of Substantially Equivalent on Mar 26, 2025. The device falls under product code QPF (Pediatric Autism Spectrum Disorder Diagnosis Aid), a Class II device regulated under 21 CFR 882.1491. Earlitec Diagnostics has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 26, 2025
- Date Received
- Dec 18, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Device Class
- Class II
- Regulation Number
- 882.1491
- Review Panel
- NE
- Submission Type
A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.