510(k) K161140 ยท JIX Calibrator, Multi-Analyte Mixture
VITROS Chemistry Products Calibrator Kit 3
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, May 20, 2016 |
| Received | Apr 22, 2016 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K161140
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.