Clearance Summary
VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III received FDA 510(k) clearance under submission number K123930, 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 2013-05-15.
- Submission: K123930
- 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: 2013-05-15
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.