Clearance Summary
OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 received FDA 510(k) clearance under submission number K043202, 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 2004-12-23.
- Submission: K043202
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 2004-12-23
Classification & Regulation
This clearance is catalogued under FDA product code CGS and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.