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

Clearance details

Applicant

Home Diagnostics, Inc.

Product code

Code JJX

Device class

Class 1

Regulation

21 CFR 862.1660

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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• K060793 — ELEMENT BLOOD GLUCOSE TEST SYSTEM2006-07-25

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 →

• Z-2882-2016 — TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a professional setting or by self-testing.Class II·Ongoing·Trividia Health·20160628

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042080.