SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K100398

Substantially Equivalent

Standard Diagnostics, Inc.

FDA 510(k) clearance K100398 for SMARTLINK GOLD BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2010-06-09. Applicant: Standard Diagnostics, Inc..

Clearance details

Applicant: Standard Diagnostics, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2010-02-16
Decision date: 2010-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Great Neck, NY, US

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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.