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

    HUMAN C5 RID KITS

    K Number: K942326 · Decision Aug 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    4
    Review Days
    468

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    Basic Information

    Device Name
    HUMAN C5 RID KITS
    K Number
    K942326
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5240
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jay H. Geller
    Date Received
    May 13, 1994
    Decision Date
    August 24, 1995
    Product Code
    DAY
    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
    DAY Complement C5, Antigen, Antiserum, Control

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    Other Clearances by Jay H. Geller

    K Number Device Name
    K971658 MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT
    K950015 HUMAN PROTEIN C RID TEST KIT
    K943334 HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT