510(k) K163587 ยท OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
VERIFY Incubator for Assert Self Contained Biological Indicators
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Mar 24, 2017 |
| Received | Dec 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163587
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.