510(k) K163646 ยท FRC Indicator, Biological Sterilization Process
Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
| Applicant | Terragene S.A., Rosario, AR |
| Decision | Substantially Equivalent, Nov 2, 2017 |
| Received | Dec 23, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163646
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2025 | TERRAGENE S.A. ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. Open, Classified |
FRC | None listed |
| Jan 26, 2024 | TERRAGENE S.A. Terragene Bionova PCD (PCD222-C) Open, Classified |
FRC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.