Clearance Summary
K-Z CONCENTRATE received FDA 510(k) clearance under submission number K781011, sponsored by K-Zyme Labs, 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 1978-08-17.
- Submission: K781011
- Applicant / Sponsor: K-Zyme Labs, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5900
- Decision date: 1978-08-17
Classification & Regulation
This clearance is catalogued under FDA product code EXB and 21 CFR 876.5900, within the Gastroenterology, Urology review panel as a Class I device.