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

    IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST

    K Number: K911849 · Decision May 7, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    23
    Review Days
    11

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    Basic Information

    Device Name
    IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST
    K Number
    K911849
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    General Biometrics, Inc.
    Date Received
    April 26, 1991
    Decision Date
    May 7, 1991
    Product Code
    LKO
    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
    LKO Anti-Rnp Antibody, Antigen And Control

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    Other Clearances by General Biometrics, Inc.

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    K911848 IMMUNOWELL RNP/SM ANTIBODY TEST
    K911851 IMMUNOWELL SM ANTIBODY TEST
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