510(k) K143236 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
Theranos Herpes Simplex Virus-1 IgG Assay
| Applicant | Theranos, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jul 2, 2015 |
| Received | Nov 12, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143236
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.