510(k) K951537 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER ELITE M BLOOD GLUCOSE METER
| Applicant | Bayer Corp., Mishawaka IN, US |
| Decision | Substantially Equivalent, Jul 14, 1995 |
| Received | Apr 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951537
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.