Clearance Summary
VITROS CHEMISTRY PRODUCTS TRFRN REAHENT; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUCTS PROTEIN received FDA 510(k) clearance under submission number K042477, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-11-19.
- Submission: K042477
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5880
- Decision date: 2004-11-19
Classification & Regulation
This clearance is catalogued under FDA product code DDG and 21 CFR 866.5880, within the Immunology review panel as a Class II device.