Clearance Summary
FORMASURE TEST REAGENT received FDA 510(k) clearance under submission number K905217, sponsored by Di-Chem, 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 1991-04-09.
- Submission: K905217
- Applicant / Sponsor: Di-Chem, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 1991-04-09
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.