510(k) K021486 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
HERPESELECT 2 ELISA IGG, MODEL ELO920G
| Applicant | Focus Technologies, Inc., Cypress CA, US |
| Decision | Substantially Equivalent, Aug 1, 2002 |
| Received | May 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021486
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.