Clearance Summary
FAST FORMALERT received FDA 510(k) clearance under submission number K853555, sponsored by Organon Teknika Corp.. 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 1986-06-26.
- Submission: K853555
- Applicant / Sponsor: Organon Teknika Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1986-06-26
Classification & Regulation
This clearance is catalogued under FDA product code KOC and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.