Clearance Summary
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/30 received FDA 510(k) clearance under submission number K002694, sponsored by Diagnostic Chemicals , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-09-15.
- Submission: K002694
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 2000-09-15
Classification & Regulation
This clearance is catalogued under FDA product code CDQ and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.