510(k) K897015 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER GX BLOOD GLUCOSE METER
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Mar 29, 1990 |
| Received | Dec 19, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K897015
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.