Clearance Summary
VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 received FDA 510(k) clearance under submission number K061464, sponsored by Ortho-Clinical Diagnostics, 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 2006-06-15.
- Submission: K061464
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1415
- Decision date: 2006-06-15
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.