Clearance Summary
UREA-SL ASSAY CATALOGUE NUMBER 239-10, 239-30 received FDA 510(k) clearance under submission number K973931, 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 1997-11-24.
- Submission: K973931
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1997-11-24
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.