510(k) K955360 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
| Applicant | Incstar Corp., Stillwater MN, US |
| Decision | Substantially Equivalent, Jul 22, 1996 |
| Received | Nov 22, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955360
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.