Clearance Summary
ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS received FDA 510(k) clearance under submission number K972004, sponsored by Alko Diagnostic 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 1997-06-16.
- Submission: K972004
- Applicant / Sponsor: Alko Diagnostic Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1170
- Decision date: 1997-06-16
Classification & Regulation
This clearance is catalogued under FDA product code CGZ and 21 CFR 862.1170, within the Clinical Chemistry review panel as a Class II device.