Clearance Summary
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS received FDA 510(k) clearance under submission number K061588, sponsored by Ortho-Clinical Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2006-07-21.
- Submission: K061588
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1377
- Decision date: 2006-07-21
Classification & Regulation
This clearance is catalogued under FDA product code LPS and 21 CFR 862.1377, within the Clinical Chemistry review panel as a Class II device.