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Terragene S.A.

FDA 510(k) & PMA Approved Dispositivos — 7 products

Total de dispositivos7
Categorias0
Última decisão da FDA
TipoNúmeroNome do dispositivoCódigoDataAções
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)FRC2024-12-12 Ver
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)FRC2024-09-18 Ver
510(k) K232103 Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)QKM2024-04-05 Ver
510(k) K221641 Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)FRC2023-02-28 Ver
510(k) K200272 Terragene ChemdyeJOJ2020-06-30 Ver
510(k) K191021 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene ChemdyeFRC2019-09-13 Ver
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 IncubatorFRC2017-11-02 Ver
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