510(k) K230337
K230337 is an FDA 510(k) premarket notification submitted by Earlitec Diagnostics, Inc. for the device "EarliPoint". The FDA issued a decision of Substantially Equivalent on Jun 29, 2023. 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, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 29, 2023
- Date Received
- Feb 7, 2023
- Clearance Type
- Traditional
- 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.