510(k) K170938 ยท JIT Calibrator, Secondary
CalSet IGF-1
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 26, 2017 |
| Received | Mar 30, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170938
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.