510(k) K162173 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Elecsys CYFRA 21-1 CalCheck 5
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Jan 12, 2017 |
| Received | Aug 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162173
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.