Clearance Summary
ENZYMATIC GLUCOSE REAGENT SINGLE VIAL GLUCOSE OXID received FDA 510(k) clearance under submission number K860726, 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 1986-04-21.
- Submission: K860726
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 1986-04-21
Classification & Regulation
This clearance is catalogued under FDA product code LFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.