Clearance Summary
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( received FDA 510(k) clearance under submission number K964767, sponsored by R&D Systems, 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 1997-05-29.
- Submission: K964767
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5630
- Decision date: 1997-05-29
Classification & Regulation
This clearance is catalogued under FDA product code JZG and 21 CFR 866.5630, within the Immunology review panel as a Class II device.