510(k) K960434 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
| Applicant | Incstar Corp., Stillwater MN, US |
| Decision | Substantially Equivalent, Oct 17, 1996 |
| Received | Jan 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960434
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.