Clearance Summary
OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 received FDA 510(k) clearance under submission number K041793, 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 2004-07-16.
- Submission: K041793
- Applicant / Sponsor: Olympus America, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1415
- Decision date: 2004-07-16
Classification & Regulation
This clearance is catalogued under FDA product code JMO and 21 CFR 862.1415, within the Clinical Chemistry review panel as a Class I device.