510(k) K971145 ยท CGA Glucose Oxidase, Glucose
GLUCOSITE TEST SYSTEM
| Applicant | Gds Technology, LLC, Elkhart IN, US |
| Decision | Substantially Equivalent, Sep 17, 1997 |
| Received | Mar 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971145
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.