Total clearances
4
2022-06-08 → 2026-03-05
Name variants in FDA filings: Earlitec Diagnostics / Earlitec Diagnostics, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QPF |
Pediatric Autism Spectrum Disorder Diagnosis Aid |
Class II |
Neurology |
4 |
2026-03-05 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-03-05 |
K253442 |
EarliPoint Assessment |
QPF |
Class II |
Neurology |
| 2025-03-26 |
K243891 |
EarliPoint System |
QPF |
Class II |
Neurology |
| 2023-06-29 |
K230337 |
EarliPoint |
QPF |
Class II |
Neurology |
| 2022-06-08 |
K213882 |
EarliPoint System |
QPF |
Class II |
Neurology |