Clearance Summary
BIOLOGIC DT-1000 MACHINE received FDA 510(k) clearance under submission number K923046, sponsored by Hemocleanse, 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 1994-09-30.
- Submission: K923046
- Applicant / Sponsor: Hemocleanse, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 1994-09-30
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.