Clearance Summary
QM300 APOLIPOPROTEIN A-I ANTIBODY PACK received FDA 510(k) clearance under submission number K883713, sponsored by Kallestad Diag, A Div. of Erbamont, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1988-10-19.
- Submission: K883713
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 1988-10-19
Classification & Regulation
This clearance is catalogued under FDA product code MSJ and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.