510(k) K080641 ยท NBW System, Test, Blood Glucose, Over The Counter
TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
| Applicant | Home Diagnostics, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 19, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080641
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.