Clearance Summary
QM300 TRANSFERRIN ANTIBODY PACK received FDA 510(k) clearance under submission number K873789, sponsored by Kallestad Diag, A Div. of Erbamont, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1987-10-07.
- Submission: K873789
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5880
- Decision date: 1987-10-07
Classification & Regulation
This clearance is catalogued under FDA product code DDG and 21 CFR 866.5880, within the Immunology review panel as a Class II device.