510(k) K062058 ยท NBW System, Test, Blood Glucose, Over The Counter
ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080
| Applicant | Bayer Healthcare, Mishawaka IN, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Jul 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062058
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 19, 2011 | Bayer Healthcare, LLC Contour, Contour TS Blood Glucose Test Strips and Bonus Packs
Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood Terminated |
LFR | None listed |
| Jul 3, 2007 | Bayer Healthcare LLC Ascensia Contour Blood Glucose Monitoring System ( Bayer )Diabetes Care System; Product 7152A.---NO USA Units are affected---. Terminated |
LFR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.