K843528

Substantially Equivalent

GLUCOSE OXIDASE ENZYMATIC REAGENT SET

Applicant: Livonia Diagnostics, Inc.
Product code: CGA
Advisory panel: Clinical Chemistry
Date received: 1984-09-07
Decision date: 1984-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Adverse events under product code CGA

product code CGA

Death: 2
Malfunction: 1,816
Total: 1,818

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.