Clearance Summary
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay received FDA 510(k) clearance under submission number K253358, sponsored by Diazyme Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2025-12-19.
- Submission: K253358
- Applicant / Sponsor: Diazyme Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 2025-12-19
Classification & Regulation
This clearance is catalogued under FDA product code DFH and 21 CFR 866.5550, within the Immunology review panel as a Class II device.