510(k) K871339— KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM

Substantially Equivalent

Kallestad Diag, A Div. of Erbamont, Inc.

Clearance details

Applicant: Kallestad Diag, A Div. of Erbamont, Inc.
Product code: Code JQP
Advisory panel: Clinical Chemistry
Date received: 1987-04-02
Decision date: 1987-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Adverse events under product code JQP

product code JQP

Death: 3
Malfunction: 690
Total: 693

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.