Clearance Summary
VITROS CHEMISTRY PRODUCTS AST SLIDE AND CHEMISTRY PRODUCTS CALIBRATOR KIT 3 received FDA 510(k) clearance under submission number K001679, 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 2000-06-28.
- Submission: K001679
- Applicant / Sponsor: Ortho-Clinical Diagnostics, Inc.
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1100
- Decision date: 2000-06-28
Classification & Regulation
This clearance is catalogued under FDA product code CIT and 21 CFR 862.1100, within the Clinical Chemistry review panel as a Class II device.