Clearance Summary
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument received FDA 510(k) clearance under submission number K142993, sponsored by Orion Diagnostica, OY. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2016-03-10.
- Submission: K142993
- Applicant / Sponsor: Orion Diagnostica, OY
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5270
- Decision date: 2016-03-10
Classification & Regulation
This clearance is catalogued under FDA product code DCK and 21 CFR 866.5270, within the Immunology review panel as a Class II device.