Clearance Summary
ENZYMATIC URIC ACID REAGENT received FDA 510(k) clearance under submission number K860732, sponsored by Trace Scientific , 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 1986-04-16.
- Submission: K860732
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1775
- Decision date: 1986-04-16
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.