510(k) K162276 ยท MXJ Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1
SeraQuest Herpes Type 1 Specific IgG
| Applicant | Quest International, Inc., Mami FL, US |
| Decision | Substantially Equivalent, Oct 1, 2016 |
| Received | Aug 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162276
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.