510(k) K971335 ยท LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
QUANTA LITE CMV IGG ELISA
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 1, 1997 |
| Received | Apr 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971335
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.