510(k) K904081 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM
| Applicant | Heraeus Kulzer, Inc., Elkhart IN, US |
| Decision | Substantially Equivalent, Dec 26, 1990 |
| Received | Sep 5, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904081
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.