Clearance Summary
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT received FDA 510(k) clearance under submission number K972591, sponsored by Morax. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1998-03-04.
- Submission: K972591
- Applicant / Sponsor: Morax
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5150
- Decision date: 1998-03-04
Classification & Regulation
This clearance is catalogued under FDA product code JKM and 21 CFR 866.5150, within the Immunology review panel as a Class II device.