510(k) K926360 ยท CGA Glucose Oxidase, Glucose
GLUCOFILM TEST STRIPS
| Applicant | Heraeus Kulzer, Inc., Mishawaka IN, US |
| Decision | Substantially Equivalent, Sep 8, 1993 |
| Received | Dec 21, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K926360
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.