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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact