510(k) K062543 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G
| Applicant | Focus Diagnostics, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Feb 1, 2007 |
| Received | Aug 30, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062543
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.