Medical Device Manufacturer · AR , Rosario

Terragene S.A.

8 submissions · 7 cleared · Since 2017
8
Total
7
Cleared
1
Denied

Terragene S.A. — FDA 510(k) Submissions

Terragene S.A. has submitted 8 FDA 510(k) premarket notifications since 2017, of which 7 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Indicator, Biological Sterilization Process, Biological Sterilization Indicator With Indirect Growth Detection, Indicator, Physical/chemical Sterilization Process, A Chemical Vapor Sterilization Multivariable Chemical Indicator . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
Terragene? Bionova? Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene? Bionova? Photon Process Challenge Device with moving-front integrator (PCD225-C)
K242453 · FRC Indicator, Biological... · General Hospital
Dec 2024 115d
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)
K231383 · FRC Indicator, Biological... · General Hospital
Sep 2024 495d
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
DEN220042 · QVB Biological Sterilization... · General Hospital
Jul 2024 742d
Terragene? Chemdye? Multivariable Chemical Indicator (CD40), Terragene? Chemdye? Chemical Process Indicator (CD42), Terragene? Cintape? Chemical Process Indicator Tape (CT40)
K232103 · QKM A Chemical Vapor... · General Hospital
Apr 2024 266d
Terragene? Bionova? Hyper Biological Indicator (BT98), Terragene? Bionova? Hyper Auto-reader Incubator (BHY), Terragene? Bionova? NanoBio Auto-reader Incubator (BNB)
K221641 · FRC Indicator, Biological... · General Hospital
Feb 2023 267d
Terragene Chemdye
K200272 · JOJ Indicator,... · General Hospital
Jun 2020 147d
Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
K191021 · FRC Indicator, Biological... · General Hospital
Sep 2019 149d
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
K163646 · FRC Indicator, Biological... · General Hospital
Nov 2017 314d
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