ACR ENZYMATIC GLUCOSE OXIDASE— 510(k) K812258

Substantially Equivalent

Harleco

FDA 510(k) clearance K812258 for ACR ENZYMATIC GLUCOSE OXIDASE, Substantially Equivalent on 1981-08-31. Applicant: Harleco.

Clearance details

Applicant: Harleco
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1981-08-12
Decision date: 1981-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.