510(k) K000365 ยท CGA Glucose Oxidase, Glucose
ACCU-CHEK ADVANTAGE METER
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Feb 23, 2000 |
| Received | Feb 4, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000365
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.