Clearance Summary
Procise ADL received FDA 510(k) clearance under submission number DEN220023, sponsored by Procisedx, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2023-09-29.
- Submission: DEN220023
- Applicant / Sponsor: Procisedx, Inc.
- Clearance pathway: Direct
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3115
- Decision date: 2023-09-29
Classification & Regulation
This clearance is catalogued under FDA product code QYD and 21 CFR 862.3115, within the Clinical Toxicology review panel as a Class II device.