Clearance Summary
BioPlex 2200 25-OH Vitamin D Kit received FDA 510(k) clearance under submission number K180577, sponsored by Bio-Rad Laboratories. 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 2018-06-22.
- Submission: K180577
- Applicant / Sponsor: Bio-Rad Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2018-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MRG and 21 CFR 862.1825, within the Clinical Chemistry review panel as a Class II device.