510(k) K192001 ยท FRC Indicator, Biological Sterilization Process
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device
| Applicant | Sterilucent, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Oct 22, 2019 |
| Received | Jul 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192001
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.