510(k) K183294 ยท FRC Indicator, Biological Sterilization Process
CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Jan 3, 2019 |
| Received | Nov 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183294
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.