510(k) K162673 ยท OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Aptima Herpes Simplex Viruses 1 & 2 Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 15, 2017 |
| Received | Sep 26, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162673
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.