510(k) K231383 · FRC Indicator, Biological Sterilization Process
Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
| Applicant | Terragene S.A., Alvear, AR |
| Decision | Substantially Equivalent, Sep 18, 2024 |
| Received | May 12, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231383
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.