Clearance Summary
Diazyme PLAC® Test for Lp-PLA2 Activity received FDA 510(k) clearance under submission number K203136, sponsored by Diazyme Laboratories, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2021-08-06.
- Submission: K203136
- Applicant / Sponsor: Diazyme Laboratories, Inc.
- Clearance pathway: Special
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5600
- Decision date: 2021-08-06
Classification & Regulation
This clearance is catalogued under FDA product code NOE and 21 CFR 866.5600, within the Immunology review panel as a Class II device.