510(k) K250044 ยท FRC Indicator, Biological Sterilization Process
Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Feb 6, 2025 |
| Received | Jan 10, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250044
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.