FDA 510(k) Applications Submitted by Terragene SA

FDA 510(k) Number Submission Date Device Name Applicant
K221641 06/06/2022 Terragene« Bionova« Hyper Biological Indicator (BT98), Terragene« Bionova« Hyper Auto-reader Incubator (BHY), Terragene« Bionova« NanoBio Auto-reader Incubator (BNB) Terragene SA
K163646 12/23/2016 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 Terragene SA
K200272 02/04/2020 Terragene Chemdye Terragene SA
K191021 04/17/2019 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye Terragene SA


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