FDA 510(k) Applications Submitted by Terragene SA
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| DEN220042 |
07/01/2022 |
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) |
Terragene SA |
| K231383 |
05/12/2023 |
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) |
Terragene SA |
| 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 |
| K232103 |
07/14/2023 |
Terragene« Chemdye« Multivariable Chemical Indicator (CD40), Terragene« Chemdye« Chemical Process Indicator (CD42), Terragene« Cintape« Chemical Process Indicator Tape (CT40) |
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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