510(k) K032657 ยท NBW System, Test, Blood Glucose, Over The Counter
TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIPS, AND GLUCOSE CONTROL SOLUTIONS (LOW AND HIGH)
| Applicant | Home Diagnostics, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Mar 24, 2004 |
| Received | Aug 28, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032657
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 28, 2016 | Trividia Health 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 Open, Classified |
NBW | None listed |
| Feb 3, 2014 | Nipro Diagnostics, Inc. MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A.
Is intend Terminated |
NBW | None listed |
| Apr 18, 2013 | Nipro Diagnostics, Inc. Duane Reade TRUEtrack monitor kit, UPC# 6 39194 01679 7 Part # A4006-81
The TRUEtrack Blood Glucose System is intended for the quantitative determination of glucose in human whole blood taken from fi Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.