Clearance Summary
BIO-CARB D16000, D16001, AND D17000 received FDA 510(k) clearance under submission number K861646, sponsored by Societe D' Analyses Bio-Pharmaceutiques,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 1986-08-07.
- Submission: K861646
- Applicant / Sponsor: Societe D' Analyses Bio-Pharmaceutiques,Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5830
- Decision date: 1986-08-07
Classification & Regulation
This clearance is catalogued under FDA product code FJH and 21 CFR 876.5830, within the Gastroenterology, Urology review panel as a Class II device.