Cognoa ASD Diagnosis Aid
FDA 510(k) clearance DEN200069 · decided 2021-06-02
Clearance details
- K-number
- DEN200069
- Device name
- Cognoa ASD Diagnosis Aid
- Applicant
- Cognoa, Inc.
- Decision
- Unknown
- Date received
- 2020-11-03
- Decision date
- 2021-06-02
- Days to decision
- 211 days
- Clearance type
- Direct
- Product code
- QPF
- Device class
- 2
- Regulation number
- 882.1491
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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| EarliPoint Assessment (K253442) | Earlitec Diagnostics | 2026-03-05 |
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Recalls involving this device
No recalls on record reference this clearance.