TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM— 510(k) K042080

Substantially Equivalent

Home Diagnostics, Inc.

FDA 510(k) clearance K042080 for TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM, Substantially Equivalent on 2004-08-19. Applicant: Home Diagnostics, Inc..

Clearance details

Applicant: Home Diagnostics, Inc.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2004-08-03
Decision date: 2004-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Fort Lauderdale, FL, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.