510(k) K142133 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Oct 24, 2014 |
| Received | Aug 4, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142133
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.