510(k) K963500 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER DEX DIABETES CARE SYSTEM
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Jan 21, 1997 |
| Received | Sep 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963500
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.