510(k) K082201 ยท NBW System, Test, Blood Glucose, Over The Counter
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A
| Applicant | U. S. Diagnostics, Inc., New York NY, US |
| Decision | Substantially Equivalent, Feb 20, 2009 |
| Received | Aug 5, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082201
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.