Clearance Summary
QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) received FDA 510(k) clearance under submission number K936016, sponsored by R&D Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1994-07-19.
- Submission: K936016
- Applicant / Sponsor: R&D Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7250
- Decision date: 1994-07-19
Classification & Regulation
This clearance is catalogued under FDA product code GGT and 21 CFR 864.7250, within the Hematology review panel as a Class II device.