510(k) K001846 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS INSULIN CALCHECK
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Jun 28, 2000 |
| Received | Jun 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001846
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.