510(k) K090628 ยท NBW System, Test, Blood Glucose, Over The Counter
DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080
| Applicant | Bayer Healthcare, LLC, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 4, 2009 |
| Received | Mar 9, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090628
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.