Clearance Summary
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET received FDA 510(k) clearance under submission number K133410, sponsored by Diazyme 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 2014-03-14.
- Submission: K133410
- Applicant / Sponsor: Diazyme Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2014-03-14
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.