510(k) K964630 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER ELITE BLOOD GLUCOSE METER
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Nov 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964630
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.