Clearance Summary
Diazyme Colorimetric Lithium Assay received FDA 510(k) clearance under submission number K243462, sponsored by Diazyme Laboratories, 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 2025-08-01.
- Submission: K243462
- Applicant / Sponsor: Diazyme Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3560
- Decision date: 2025-08-01
Classification & Regulation
This clearance is catalogued under FDA product code NDW and 21 CFR 862.3560, within the Clinical Toxicology review panel as a Class II device.