Clearance Summary
ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT received FDA 510(k) clearance under submission number DEN140001, sponsored by Kronus Market Development Associates, Inc.. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2014-08-20.
- Submission: DEN140001
- Applicant / Sponsor: Kronus Market Development Associates, Inc.
- Clearance pathway: Post-NSE
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5670
- Decision date: 2014-08-20
Classification & Regulation
This clearance is catalogued under FDA product code PHF and 21 CFR 866.5670, within the Immunology review panel as a Class II device.