510(k) K181213 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 30, 2018 |
| Received | May 7, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181213
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.