510(k) K934898 ยท CGA Glucose Oxidase, Glucose
GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, Dec 7, 1993 |
| Received | Oct 13, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934898
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.