510(k) K153683 ยท POV Semen Analysis Device
Trak Male Fertility Testing System
| Applicant | Sandstone Diagnostics, Inc., Livermore CA, US |
| Decision | Substantially Equivalent, May 16, 2016 |
| Received | Dec 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153683
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.