510(k) K221641 · FRC Indicator, Biological Sterilization Process
Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
| Applicant | Terragene S.A., Alvear, AR |
| Decision | Substantially Equivalent, Feb 28, 2023 |
| Received | Jun 6, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221641
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.