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

    ACUSCREEN

    K Number: K822782 · Decision Oct 8, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    126
    Review Days
    24

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    Basic Information

    Device Name
    ACUSCREEN
    K Number
    K822782
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7925
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Ortho Diagnostic Systems, Inc.
    Date Received
    September 14, 1982
    Decision Date
    October 8, 1982
    Product Code
    GGW
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GGW Test, Time, Partial Thromboplastin

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