Clearance Summary
HMB32 Dialysis Solution received FDA 510(k) clearance under submission number K212052, sponsored by Haemopharm Biofluids S.R.L.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2021-07-23.
- Submission: K212052
- Applicant / Sponsor: Haemopharm Biofluids S.R.L.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2021-07-23
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.