Clearance Summary
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II received FDA 510(k) clearance under submission number K142595, 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 2015-06-04.
- Submission: K142595
- Applicant / Sponsor: Ortho Clinical Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1373
- Decision date: 2015-06-04
Classification & Regulation
This clearance is catalogued under FDA product code PDJ and 21 CFR 862.1373, within the Clinical Chemistry review panel as a Class II device.