Clearance Summary
STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS received FDA 510(k) clearance under submission number K030650, sponsored by Uridynamics, Inc.. 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 2003-04-14.
- Submission: K030650
- Applicant / Sponsor: Uridynamics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1550
- Decision date: 2003-04-14
Classification & Regulation
This clearance is catalogued under FDA product code CEN and 21 CFR 862.1550, within the Clinical Chemistry review panel as a Class I device.