510(k) K071510 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
HERPESELECT EXPRESS IGG, HERPESELECT EXPRESS CONTROLS, MODELS RT0920G, RT0950
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Sep 24, 2007 |
| Received | Jun 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071510
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.