510(k) K982027 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Nov 25, 1998 |
| Received | Jun 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982027
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.