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

    ADP ANA APPLEZYME

    K Number: K843745 · Decision Oct 25, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    111
    Applicant Total
    7
    Review Days
    30

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    Basic Information

    Device Name
    ADP ANA APPLEZYME
    K Number
    K843745
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Apple Diagnostic Products
    Date Received
    September 25, 1984
    Decision Date
    October 25, 1984
    Product Code
    LJM
    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
    LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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    Other Clearances by Apple Diagnostic Products

    K Number Device Name
    K844287 ADPIFA TEST FOR ANTIBODIES TO TOXOPLASMA GONDII
    K843120 APPLELISA CHLAMYDIA TRACHOMATIS ANTI
    K842707 ADP NDNA IFA TEST
    K842183 ADP ANA IFA TEST
    K834241 ANA APPLELISA
    K834242 ADP IFA TEST FOR CHLAMYDIAE TRACHOMATIS