TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS— 510(k) K030703

Substantially Equivalent

Home Diagnostics, Inc.

FDA 510(k) clearance K030703 for TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMART SYSTEM BLOOD GLUCOSE TEST STRIPS, Substantially Equivalent on 2003-07-11. Applicant: Home Diagnostics, Inc..

Clearance details

Applicant: Home Diagnostics, Inc.
Product code: Code NBW
Advisory panel: Clinical Chemistry
Date received: 2003-03-06
Decision date: 2003-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Lauderdale, FL, 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.