510(k) K242453 · FRC Indicator, Biological Sterilization Process
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
| Applicant | Terragene S.A., Alvear, AR |
| Decision | Substantially Equivalent, Dec 12, 2024 |
| Received | Aug 19, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242453
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.