510(k) K163144 ยท FRC Indicator, Biological Sterilization Process
gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)
| Applicant | Gke-GmbH, Waldems, DE |
| Decision | Substantially Equivalent, Apr 7, 2017 |
| Received | Nov 9, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163144
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.