Clearance Summary
FORMA-FAS-TEST received FDA 510(k) clearance under submission number K833128, sponsored by Chemical Detection & Experimentation. 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 1984-06-27.
- Submission: K833128
- Applicant / Sponsor: Chemical Detection & Experimentation
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1984-06-27
Classification & Regulation
This clearance is catalogued under FDA product code LIF and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.