Clearance Summary
UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 received FDA 510(k) clearance under submission number K993178, sponsored by Diagnostic Chemicals , 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 1999-10-18.
- Submission: K993178
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1999-10-18
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.