Clearance Summary
PELICLASS HUMAN IGG SUBCLASS NEPHELOMETRIC IMMAGE KIT received FDA 510(k) clearance under submission number K020823, sponsored by Sanquin Blood Supply Foundation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-05-14.
- Submission: K020823
- Applicant / Sponsor: Sanquin Blood Supply Foundation
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5510
- Decision date: 2002-05-14
Classification & Regulation
This clearance is catalogued under FDA product code DFZ and 21 CFR 866.5510, within the Immunology review panel as a Class II device.