Clearance Summary
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer received FDA 510(k) clearance under submission number K212221, sponsored by Diazyme Laboratories, Inc.. 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 2021-12-13.
- Submission: K212221
- Applicant / Sponsor: Diazyme Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2021-12-13
Classification & Regulation
This clearance is catalogued under FDA product code DHA and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.