510(k) K905077 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
ORTHO CMV-M ANTIBODY ELISA TEST
| Applicant | Ortho Diagnostic Systems, Inc., Carpinteria CA, US |
| Decision | Substantially Equivalent, Dec 17, 1990 |
| Received | Nov 13, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905077
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.