Clearance Summary
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay received FDA 510(k) clearance under submission number K252336, sponsored by Diazyme Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Unknown review panel. The statutory decision date of record is 2026-04-24.
- Submission: K252336
- Applicant / Sponsor: Diazyme Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Unknown
- Device class:
- Decision date: 2026-04-24
Classification & Regulation
This clearance is catalogued under FDA product code , within the Unknown review panel as a device.