Clearance Summary
URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING received FDA 510(k) clearance under submission number K001810, sponsored by Flexsite Diagnostics, 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 2000-08-14.
- Submission: K001810
- Applicant / Sponsor: Flexsite Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 2000-08-14
Classification & Regulation
This clearance is catalogued under FDA product code JIR and 21 CFR 862.1645, within the Clinical Chemistry review panel as a Class I device.