Clearance Summary
LZI Buprenorphine II Enzyme Immunoassay received FDA 510(k) clearance under submission number K253082, sponsored by Lin-Zhi International, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 2026-01-16.
- Submission: K253082
- Applicant / Sponsor: Lin-Zhi International, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3650
- Decision date: 2026-01-16
Classification & Regulation
This clearance is catalogued under FDA product code DJG and 21 CFR 862.3650, within the Clinical Toxicology review panel as a Class II device.