510(k) K131334 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
HERPES SIMPLEX VIRUS TYPE 1 IGG ELISA TEST
| Applicant | Gold Standard Diagnostics, Davis CA, US |
| Decision | Substantially Equivalent, Feb 28, 2014 |
| Received | May 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131334
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.