Clearance Summary
THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS received FDA 510(k) clearance under submission number K041427, sponsored by Arkray, Inc.. 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 2004-11-24.
- Submission: K041427
- Applicant / Sponsor: Arkray, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2004-11-24
Classification & Regulation
This clearance is catalogued under FDA product code CGA and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.