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 |