Clearance Summary
Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set received FDA 510(k) clearance under submission number K161646, 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 2016-11-04.
- Submission: K161646
- Applicant / Sponsor: Diazyme Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1295
- Decision date: 2016-11-04
Classification & Regulation
This clearance is catalogued under FDA product code CGN and 21 CFR 862.1295, within the Clinical Chemistry review panel as a Class II device.