Clearance Summary
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE received FDA 510(k) clearance under submission number K090338, sponsored by Reprocessing Products 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 2009-05-08.
- Submission: K090338
- Applicant / Sponsor: Reprocessing Products Corp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2009-05-08
Classification & Regulation
This clearance is catalogued under FDA product code MSY and 21 CFR 876.5665, within the Gastroenterology, Urology review panel as a Class II device.