Clearance Summary
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips received FDA 510(k) clearance under submission number K232317, 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 2024-04-26.
- Submission: K232317
- 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: 2024-04-26
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.