510(k) K933389 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
OPUS CMV-G
| Applicant | Pb Diagnostic Systems, Inc., Westwood MA, US |
| Decision | Substantially Equivalent, Jun 28, 1994 |
| Received | Jul 12, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933389
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.