510(k) K061239 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
| Applicant | Euroimmun Us, LLC, Boonton Township NJ, US |
| Decision | Substantially Equivalent, Jun 28, 2007 |
| Received | May 3, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061239
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.