Procise ADL
FDA 510(k) clearance DEN220023 · decided 2023-09-29
Clearance details
- K-number
- DEN220023
- Device name
- Procise ADL
- Applicant
- Procisedx, Inc.
- Decision
- Unknown
- Date received
- 2022-04-04
- Decision date
- 2023-09-29
- Days to decision
- 543 days
- Clearance type
- Direct
- Product code
- QYD
- Device class
- 2
- Regulation number
- 862.3115
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.