Clearance Summary
AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY received FDA 510(k) clearance under submission number K800820, 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 1980-04-24.
- Submission: K800820
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5120
- Decision date: 1980-04-24
Classification & Regulation
This clearance is catalogued under FDA product code DBE and 21 CFR 866.5120, within the Immunology review panel as a Class II device.