510(k) K080960 ยท NBW System, Test, Blood Glucose, Over The Counter
PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS
| Applicant | Abbott Diabetes Care, Inc., Alameda CA, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Apr 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080960
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.