510(k) K162945 ยท OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
VERIFY ASSERT STEAM Process Challenge Device
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Apr 28, 2017 |
| Received | Oct 21, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162945
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.