Clearance Summary
E-Z CHECK OZONE TEST STRIPS received FDA 510(k) clearance under submission number K132344, sponsored by Reprocessing Products Corporation (Rpc). 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 2014-02-25.
- Submission: K132344
- Applicant / Sponsor: Reprocessing Products Corporation (Rpc)
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5665
- Decision date: 2014-02-25
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.