510(k) K251122 · FRC Indicator, Biological Sterilization Process
Terragene® Bionova® BT20 Biological Indicator
| Applicant | Terragene, Alvear, AR |
| Decision | Substantially Equivalent, Aug 4, 2025 |
| Received | Apr 11, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251122
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.