Clearance Summary
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK received FDA 510(k) clearance under submission number K896483, 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 1989-12-01.
- Submission: K896483
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5620
- Decision date: 1989-12-01
Classification & Regulation
This clearance is catalogued under FDA product code DEB and 21 CFR 866.5620, within the Immunology review panel as a Class II device.