510(k) K033105 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
CAPTIA HSV 1 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 K033105
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.