Clearance Summary
ADVIA Centaur Erythropoietin (EPO) assay received FDA 510(k) clearance under submission number K183088, sponsored by Axis-Shield Diagnostics Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2019-08-02.
- Submission: K183088
- Applicant / Sponsor: Axis-Shield Diagnostics Limited
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7250
- Decision date: 2019-08-02
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.