BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MID-LEVEL IGG KIT CAT. NO. 9315

    K Number: K891299 · Decision Mar 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    280
    Review Days
    9

    Basic Information

    Device Name
    MID-LEVEL IGG KIT CAT. NO. 9315
    K Number
    K891299
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5540
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    HELENA LABORATORIES
    Date Received
    March 13, 1989
    Decision Date
    March 22, 1989
    Product Code
    DAQ
    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
    DAQ Igg (Fd Fragment Specific), Antigen, Antiserum, Control

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