510(k) K080643 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
ELECSYS ANTI-TSHR CALCHECK
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 22, 2008 |
| Received | Mar 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080643
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.