GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM— 510(k) K904081

Substantially Equivalent

Heraeus Kulzer, Inc.

FDA 510(k) clearance K904081 for GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM, Substantially Equivalent on 1990-12-26. Applicant: Heraeus Kulzer, Inc..

Clearance details

Applicant: Heraeus Kulzer, Inc.
Product code: Code CGA
Advisory panel: Clinical Chemistry
Date received: 1990-09-05
Decision date: 1990-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, 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.