510(k) K984346 ยท LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 25, 1999 |
| Received | Dec 4, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984346
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.