Clearance Summary
HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER received FDA 510(k) clearance under submission number K012328, sponsored by Di-Chem, 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 2002-01-18.
- Submission: K012328
- Applicant / Sponsor: Di-Chem, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2002-01-18
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.