510(k) K190879 ยท DFH Kappa, Antigen, Antiserum, Control
N Latex FLC kappa, N Latex FLC lambda
| Applicant | Siemens Healthcare Diagnostics Products GmbH, Marburg, DE |
| Decision | Substantially Equivalent, May 3, 2019 |
| Received | Apr 4, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190879
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.