MICRODOT BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K070524

Substantially Equivalent

Cambridge Sensors Limited

FDA 510(k) clearance K070524 for MICRODOT BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2007-06-22. Applicant: Cambridge Sensors Limited.

Clearance details

Applicant: Cambridge Sensors Limited
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2007-02-23
Decision date: 2007-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntingdon, Cambridgeshire, GB

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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.