510(k) K160712 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
VITROS Chemistry Products hsCRP Reagent
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Jul 14, 2017 |
| Received | Mar 15, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160712
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.