510(k) K230337
- Device
- EarliPoint
- Applicant
- Earlitec Diagnostics, Inc.
- 510(k) number
- K230337
- Product code
- QPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-06-29
- Date received
- 2023-02-07
- Regulation
- 882.1491
- Classification name
- Pediatric Autism Spectrum Disorder Diagnosis Aid
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ryan Bormann
- Address
- 755 Commerce Dr., Suite 700 Atlanta GA US 30030 30030
FDA Registration Numbers#
- 3020832299
- 3027553518
Source Documents#
Other 510(k) Records For Product Code QPF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253442 | EarliPoint Assessment | Earlitec Diagnostics | 2026-03-05 |
| K243558 | Canvas Dx | Cognoa, Inc. | 2025-04-11 |
| K243891 | EarliPoint System | Earlitec Diagnostics | 2025-03-26 |
| K213882 | EarliPoint System | Earlitec Diagnostics, Inc. | 2022-06-08 |
| DEN200069 | Cognoa ASD Diagnosis Aid | Cognoa, Inc. | 2021-06-02 |