510(k) K160202 ยท LEH Radioimmunoassay, Vancomycin
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 27, 2016 |
| Received | Jan 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160202
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.