510(k) K090495 ยท NBW System, Test, Blood Glucose, Over The Counter
TRUEBALANCE BLOOD GLUCOSE SYSTEM
| Applicant | Home Diagnostics, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Mar 27, 2009 |
| Received | Feb 25, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090495
| 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 TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A.
Is inte Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.