510(k) K152353 ยท MYF Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2
SeraQuest HSV Type 2 Specific IgG
| Applicant | Quest International, Inc., Mami FL, US |
| Decision | Substantially Equivalent, May 13, 2016 |
| Received | Aug 20, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152353
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.