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

    ORTHO DNA PROBE HSV CONFIRMATION TEST

    K Number: K852360 · Decision Sep 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    36
    Applicant Total
    126
    Review Days
    100

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    Basic Information

    Device Name
    ORTHO DNA PROBE HSV CONFIRMATION TEST
    K Number
    K852360
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    June 4, 1985
    Decision Date
    September 12, 1985
    Product Code
    GQL
    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
    GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

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