Clearance Summary
VITROS CHEMISTRY PRODUCT MALB REAGENT, CALIBRATOR KIT 24, MALB PERFORMANCE VERIFIERS I AND II received FDA 510(k) clearance under submission number K042643, 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 2004-11-18.
- Submission: K042643
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5040
- Decision date: 2004-11-18
Classification & Regulation
This clearance is catalogued under FDA product code DCF and 21 CFR 866.5040, within the Immunology review panel as a Class II device.