Clearance Summary
QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) received FDA 510(k) clearance under submission number K970718, 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 1997-05-27.
- Submission: K970718
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5880
- Decision date: 1997-05-27
Classification & Regulation
This clearance is catalogued under FDA product code JNM and 21 CFR 866.5880, within the Immunology review panel as a Class II device.