Clearance Summary
CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS received FDA 510(k) clearance under submission number K052525, sponsored by DFI Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-03-29.
- Submission: K052525
- Applicant / Sponsor: DFI Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1340
- Decision date: 2006-03-29
Classification & Regulation
This clearance is catalogued under FDA product code JIL and 21 CFR 862.1340, within the Clinical Chemistry review panel as a Class II device.