510(k) K091102 ยท CGA Glucose Oxidase, Glucose
ASSURE PLATINUM AND GLUCOCARD VITAL BLOOD GLUCOSE MONITORING SYSTEMS
| Applicant | Arkray Factory USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Oct 23, 2009 |
| Received | Apr 16, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091102
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.