BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    COLORGENE HSV DNA HYBRIDIZATION TEST

    K Number: K880604 · Decision Aug 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    173

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    Basic Information

    Device Name
    COLORGENE HSV DNA HYBRIDIZATION TEST
    K Number
    K880604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Enzo Biochem, Inc.
    Date Received
    February 12, 1988
    Decision Date
    August 3, 1988
    Product Code
    GQN
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GQN Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2

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    Other Clearances by Enzo Biochem, Inc.

    K Number Device Name
    K881907 HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
    K875367 COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV
    K872576 COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION
    K870733 COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA.