510(k) K854329 ยท CGA Glucose Oxidase, Glucose
DIAGEM 300 BG REAGENT STRIPS
| Applicant | Seton Products, Inc., Montgomeryville PA, US |
| Decision | Substantially Equivalent, Aug 4, 1986 |
| Received | Oct 28, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854329
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.