510(k) K193047 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, Jul 14, 2021 |
| Received | Nov 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193047
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.