Terragene S.A.
FDA 510(k) & PMA Approved Devices — 7 products
Total Devices7
Categories3
Latest FDA decision2024-12-12
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) | FRC | 2024-12-12 | View |
| 510(k) | K231383 | 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) | FRC | 2024-09-18 | View |
| 510(k) | K232103 | Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) | QKM | 2024-04-05 | View |
| 510(k) | K221641 | Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) | FRC | 2023-02-28 | View |
| 510(k) | K200272 | Terragene Chemdye | JOJ | 2020-06-30 | View |
| 510(k) | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye | FRC | 2019-09-13 | View |
| 510(k) | K163646 | 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 | FRC | 2017-11-02 | View |
No matching devices.