BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇷 Argentina

    Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)

    K Number: K232103 · Decision Apr 5, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    4
    Applicant Total
    8
    Review Days
    266

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    Basic Information

    Device Name
    Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
    K Number
    K232103
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Terragene S.A.
    Date Received
    July 14, 2023
    Decision Date
    April 5, 2024
    Product Code
    QKM
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QKM A Chemical Vapor Sterilization Multivariable Chemical Indicator

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    Other Clearances by Terragene S.A.

    K Number Device Name
    K242453 Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C)
    K231383 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)
    DEN220042 Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
    K221641 Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
    K200272 Terragene Chemdye
    K191021 Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye
    K163646 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