510(k) K921011 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
PHARMACIA CMV IGM ELISA
| Applicant | Pharmacia Diagnostics, Inc., Piscataway NJ, US |
| Decision | Substantially Equivalent, Jul 27, 1992 |
| Received | Mar 3, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921011
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.