510(k) K875361 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
| Applicant | Disease Detection International, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 13, 1988 |
| Received | Dec 31, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K875361
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.