510(k) K171168 ยท JIT Calibrator, Secondary
VITROS Immunodiagnostic Products Insulin Calibrators
| Applicant | Ortho Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, May 16, 2017 |
| Received | Apr 21, 2017 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K171168
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.