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FDA 510(k) Applications Submitted by Hernando Carrizo
FDA 510(k) Number
Submission Date
Device Name
Applicant
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
K242453
08/19/2024
Terragene« Bionova« Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene« Bionova« Photon Process Challenge Device with moving-front integrator (PCD225-C)
Terragene S.A.
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