510(k) K963084 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
OPUS CMV TEST SYSTEM-MODIFICATION
| Applicant | Behring Diagnostics, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Oct 9, 1996 |
| Received | Aug 8, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963084
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.