Pediatric Autism Spectrum Disorder Diagnosis Aid
Regulation 882.1491
2510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in QPF
| Company | 510(k)s | Recalls |
|---|---|---|
| Earlitec Diagnostics | 4 | 0 |
| Cognoa, Inc. | 2 | 0 |
| Argus Cognitive, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2026 | K260064 | Neurora Argus Cognitive, Inc. | QPF |
| Mar 5, 2026 | K253442 | EarliPoint Assessment Earlitec Diagnostics | QPF |
| Apr 11, 2025 | K243558 | Canvas Dx Cognoa, Inc. | QPF |
| Mar 26, 2025 | K243891 | EarliPoint System Earlitec Diagnostics | QPF |
| Jun 29, 2023 | K230337 | EarliPoint Earlitec Diagnostics, Inc. | QPF |
| Jun 8, 2022 | K213882 | EarliPoint System Earlitec Diagnostics, Inc. | QPF |
| Jun 2, 2021 | DEN200069 | Cognoa ASD Diagnosis Aid Cognoa, Inc. | QPF |
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