510(k) K014139 ยท CGA Glucose Oxidase, Glucose
DIABETES ASSISTANT SOFTWARE
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 21, 2002 |
| Received | Dec 17, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014139
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.