510(k) K063864 ยท POV Semen Analysis Device
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
| Applicant | Medical Electronic Systems , Ltd., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 26, 2007 |
| Received | Dec 29, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063864
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.