Company · AR
Terragene S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2017 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 4, 2025 | K251122 | Terragene® Bionova® BT20 Biological Indicator Terragene, AR | FRC |
| Dec 12, 2024 | K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon P Terragene S.A., AR | FRC |
| Sep 18, 2024 | K231383 | Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator Terragene S.A., AR | FRC |
| Jul 12, 2024 | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) Terragene S.A., AR | QVB |
| Apr 5, 2024 | K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terr Terragene S.A., AR | QKM |
| Feb 28, 2023 | K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Terragene S.A., AR | FRC |
| Jun 30, 2020 | K200272 | Terragene Chemdye Terragene S.A., AR | JOJ |
| Sep 13, 2019 | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye Terragene S.A., AR | FRC |
| Nov 2, 2017 | K163646 | Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222- Terragene S.A., AR | FRC |
Latest recalls
| 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 | K163646 |
| Jan 26, 2024 | TERRAGENE S.A. Terragene Bionova PCD (PCD222-C) Open, Classified |
FRC | K163646 |
| Jan 26, 2024 | TERRAGENE S.A. Terragene Integron IT26-C
Terragene Integron IT26-C with extender
Benco Dental Chemical Integrator [5726-583]
Tuttnauer (WTL198-0082)
Terragene Integron (PCD26-C)
Terragene Bionova PCD (PCD222-C) Open, Classified |
JOJ | K191021 |