510(k) K984343 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
PREMIER TYPE SPECIFIC HSV-1 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 K984343
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.