510(k) K172514 ยท POV Semen Analysis Device
Trak Plus Male Fertility Testing System
| Applicant | Sandstone Diagnostics, Inc., Livermore CA, US |
| Decision | Substantially Equivalent, Nov 17, 2017 |
| Received | Aug 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172514
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.