Clearance Summary
OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K011720, sponsored by Olympus America, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2001-06-25.
- Submission: K011720
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1035
- Decision date: 2001-06-25
Classification & Regulation
This clearance is catalogued under FDA product code CIX and 21 CFR 862.1035, within the Clinical Chemistry review panel as a Class II device.