510(k) K901485 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ENZYGNOST ANTI-CMV/IGG + IGM
| Applicant | Behring Diagnostics, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, May 20, 1991 |
| Received | Mar 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901485
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.