Clearance Summary
AFT SYSTEM PROFICIENCY TESTING PROGRAM received FDA 510(k) clearance under submission number K820088, 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 1982-01-26.
- Submission: K820088
- Applicant / Sponsor: Calbiochem-Behring Corp.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5660
- Decision date: 1982-01-26
Classification & Regulation
This clearance is catalogued under FDA product code DBL and 21 CFR 866.5660, within the Immunology review panel as a Class II device.