510(k) K053079 ยท CGA Glucose Oxidase, Glucose
ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
| Applicant | Hypoguard USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Mar 28, 2006 |
| Received | Nov 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053079
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.