Clearance Summary
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM received FDA 510(k) clearance under submission number K871339, 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 1987-05-15.
- Submission: K871339
- Applicant / Sponsor: Kallestad Diag, A Div. of Erbamont, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2100
- Decision date: 1987-05-15
Classification & Regulation
This clearance is catalogued under FDA product code JQP and 21 CFR 862.2100, within the Clinical Chemistry review panel as a Class I device.