Clearance Summary
URIC ACID-SL ASSAY CATALOGUE NO. 237-60 received FDA 510(k) clearance under submission number K961586, 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 1996-07-23.
- Submission: K961586
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1775
- Decision date: 1996-07-23
Classification & Regulation
This clearance is catalogued under FDA product code KNK and 21 CFR 862.1775, within the Clinical Chemistry review panel as a Class I device.