Clearance Summary
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS received FDA 510(k) clearance under submission number K003615, sponsored by Environmental Test Systems, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-02-01.
- Submission: K003615
- Applicant / Sponsor: Environmental Test Systems, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5820
- Decision date: 2001-02-01
Classification & Regulation
This clearance is catalogued under FDA product code FKP and 21 CFR 876.5820, within the Gastroenterology, Urology review panel as a Class II device.