BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

    K Number: K212193 · Decision Oct 22, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    205
    Applicant Total
    8
    Review Days
    100

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    Basic Information

    Device Name
    Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K Number
    K212193
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.2800
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Plasmapp Co,., Ltd.
    Date Received
    July 14, 2021
    Decision Date
    October 22, 2021
    Product Code
    FRC
    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
    FRC Indicator, Biological Sterilization Process

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    Other Clearances by Plasmapp Co,., Ltd.

    K Number Device Name
    K231169 STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K223025 Tyvek Roll with CI for STERLINK Sterilizer
    K223023 Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K223015 STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette
    K220345 STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)
    K212200 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette
    K212198 Tyvek(R) Roll with CI for STERLINKTM Sterilizer