Clearance Summary
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT received FDA 510(k) clearance under submission number K121046, sponsored by Kronus Market Development Associates, 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 2012-12-20.
- Submission: K121046
- Applicant / Sponsor: Kronus Market Development Associates, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 2012-12-20
Classification & Regulation
This clearance is catalogued under FDA product code PCG and 21 CFR 866.5660, within the Immunology review panel as a Class II device.