510(k) K913693 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ENZYGNOST(R) ANTI-CMV/IGM
| Applicant | Behring Diagnostics, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Feb 27, 1992 |
| Received | Aug 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913693
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.