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

    IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST

    K Number: K920401 · Decision Aug 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    93
    Applicant Total
    23
    Review Days
    204

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    Basic Information

    Device Name
    IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
    K Number
    K920401
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5660
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Biometrics, Inc.
    Date Received
    January 29, 1992
    Decision Date
    August 20, 1992
    Product Code
    MID
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MID System, Test, Anticardiolipin Immunological

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    Other Clearances by General Biometrics, Inc.

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