Clearance Summary
Zeus IFA ANA HEp-2 Test System, Zeus dIFine received FDA 510(k) clearance under submission number K201956, sponsored by Zeus Scientific, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2022-04-29.
- Submission: K201956
- Applicant / Sponsor: Zeus Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 2022-04-29
Classification & Regulation
This clearance is catalogued under FDA product code DHN and 21 CFR 866.5100, within the Immunology review panel as a Class II device.