510(k) K963544 ยท CGA Glucose Oxidase, Glucose
SUPREME II METER
| Applicant | Chronimed, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Feb 20, 1997 |
| Received | Sep 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963544
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.