Clearance Summary
DRI Ecstasy Plus Assay received FDA 510(k) clearance under submission number K240670, sponsored by Microgenics Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2024-10-30.
- Submission: K240670
- Applicant / Sponsor: Microgenics Corporation
- Clearance pathway: Special
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3100
- Decision date: 2024-10-30
Classification & Regulation
This clearance is catalogued under FDA product code DKZ and 21 CFR 862.3100, within the Clinical Toxicology review panel as a Class II device.