Clearance Summary
BCM DRY PACK BICARBONATE MIXER received FDA 510(k) clearance under submission number K873166, sponsored by Specialty Dialysis Services. 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 1987-12-30.
- Submission: K873166
- Applicant / Sponsor: Specialty Dialysis Services
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1987-12-30
Classification & Regulation
This clearance is catalogued under FDA product code FIN and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.