Clearance Summary
URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS received FDA 510(k) clearance under submission number K082811, sponsored by Urit Medical Electronic Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2009-09-11.
- Submission: K082811
- Applicant / Sponsor: Urit Medical Electronic Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.6550
- Decision date: 2009-09-11
Classification & Regulation
This clearance is catalogued under FDA product code JIO and 21 CFR 864.6550, within the Hematology review panel as a Class II device.