Clearance Summary
QM300 PREALBUMIN ANTIBODY PACK received FDA 510(k) clearance under submission number K883002, 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 1988-09-22.
- Submission: K883002
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5060
- Decision date: 1988-09-22
Classification & Regulation
This clearance is catalogued under FDA product code JZJ and 21 CFR 866.5060, within the Immunology review panel as a Class I device.