Clearance Summary
DIAZYME 25-HYDROXY VITAMIN D ASSAY KIT MODEL DZ688A, DIAZYME 25-HYDROXY VITAMIN D ASSAY CALIBRATOR SET MODEL DZ688A-CAL, received FDA 510(k) clearance under submission number K102432, 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 2011-01-14.
- Submission: K102432
- Applicant / Sponsor: Diazyme Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1825
- Decision date: 2011-01-14
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.