510(k) K890610 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Jun 23, 1989 |
| Received | Feb 7, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K890610
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.