510(k) K092104 ยท CGA Glucose Oxidase, Glucose
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Arkray Factory USA, Inc., Edina MN, US |
| Decision | Substantially Equivalent, Nov 24, 2009 |
| Received | Jul 14, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092104
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.