510(k) K001907 ยท CGA Glucose Oxidase, Glucose
CAMIT DIABETES MANAGEMENT SOFTWARE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 5, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001907
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.