The following data is part of a premarket notification filed by Earlitec Diagnostics, Inc. with the FDA for Earlipoint System.
| Device ID | K213882 |
| 510k Number | K213882 |
| Device Name: | EarliPoint System |
| Classification | Pediatric Autism Spectrum Disorder Diagnosis Aid |
| Applicant | EarliTec Diagnostics, Inc. 755 Commerce Drive, Suite 700 Decatur, GA 30030 |
| Contact | Thomas Ressemann |
| Correspondent | Sew-Wah Tay Libra Medical, Inc. 8401 73rd Ave N, Suite 63 Brooklyn Park, MN 55428 |
| Product Code | QPF |
| CFR Regulation Number | 882.1491 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-06-08 |