Clearance Summary
REVOLUTION RADIAL IMMUNODIFFUSION PLATE received FDA 510(k) clearance under submission number K831811, sponsored by Calbiochem-Behring Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1983-07-28.
- Submission: K831811
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4800
- Decision date: 1983-07-28
Classification & Regulation
This clearance is catalogued under FDA product code JZQ and 21 CFR 866.4800, within the Immunology review panel as a Class I device.