510(k) K063771 ยท NBW System, Test, Blood Glucose, Over The Counter
GLUCOCARD X-METER BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Arkray Factory USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Aug 9, 2007 |
| Received | Dec 21, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063771
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.