510(k) K181514 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
SeraQuest HSV Type 2 Specific IgG
| Applicant | Quest International, Inc., Palm City FL, US |
| Decision | Substantially Equivalent, Jun 13, 2019 |
| Received | Jun 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181514
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.