510(k) K061431 ยท CGA Glucose Oxidase, Glucose
EASYGLUCO, MODEL IGM-0002 G2
| Applicant | U. S. Diagnostics, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jan 12, 2007 |
| Received | May 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061431
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.