Clearance Summary
OXALATE URINE CONTROLS (NORMAL AND ELEVATED) received FDA 510(k) clearance under submission number K062521, sponsored by Thermo-Electron Corp.. 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 2007-03-16.
- Submission: K062521
- Applicant / Sponsor: Thermo-Electron Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2007-03-16
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.