Clearance Summary
ACIDIFIED COMPONENT CONCENTRATES FOR BICARBONATE DIALYSIS CONTAINING DI-ACETATE received FDA 510(k) clearance under submission number K023985, sponsored by Rockwell Medical Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-02-28.
- Submission: K023985
- Applicant / Sponsor: Rockwell Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2003-02-28
Classification & Regulation
This clearance is catalogued under FDA product code KPO and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.