Clearance Summary
VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III received FDA 510(k) clearance under submission number K042494, sponsored by Ortho-Clinical Diagnostics. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2004-10-19.
- Submission: K042494
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5240
- Decision date: 2004-10-19
Classification & Regulation
This clearance is catalogued under FDA product code CZW and 21 CFR 866.5240, within the Immunology review panel as a Class II device.