Clearance Summary
ENA TEST KIT SM & RNP AUTO ANTIBODY received FDA 510(k) clearance under submission number K831036, 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 1983-04-27.
- Submission: K831036
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5100
- Decision date: 1983-04-27
Classification & Regulation
This clearance is catalogued under FDA product code LLL and 21 CFR 866.5100, within the Immunology review panel as a Class II device.