510(k) K052207 ยท CGA Glucose Oxidase, Glucose
ACCUREX GLUCOSE TEST STRIP
| Applicant | Incline Medical, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Mar 9, 2006 |
| Received | Aug 12, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052207
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.