510(k) K001906 ยท JIS Calibrator, Primary
ELECSYS INSULIN CALSET
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jul 13, 2000 |
| Received | Jun 22, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001906
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.