510(k) K033106 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT
| Applicant | Trinity Biotech USA, Jamestown NY, US |
| Decision | Substantially Equivalent, Jul 13, 2004 |
| Received | Sep 30, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033106
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.