Clearance Summary
OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CALIBRATOR; OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA received FDA 510(k) clearance under submission number K014015, sponsored by Olympus America, 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 2002-02-08.
- Submission: K014015
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2002-02-08
Classification & Regulation
This clearance is catalogued under FDA product code LBS and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.