Clearance Summary
VITROS 5,1 FS CHEMISTRY SYSTEM, VITROS CHEMISTRY PRODUCTS DHDL REAGENT PACK, CALIBRATOR KIT 19, FS CALIBRATOR 1 received FDA 510(k) clearance under submission number K031924, sponsored by Ortho-Clinical Diagnostics. 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 2003-08-07.
- Submission: K031924
- Applicant / Sponsor: Ortho-Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1150
- Decision date: 2003-08-07
Classification & Regulation
This clearance is catalogued under FDA product code JIT and 21 CFR 862.1150, within the Clinical Chemistry review panel as a Class II device.