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

    SERUM, IGG GOAT ANTI-HUMAN ACID

    K Number: K760145 · Decision Jul 19, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    75
    Applicant Total
    9
    Review Days
    20

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    Basic Information

    Device Name
    SERUM, IGG GOAT ANTI-HUMAN ACID
    K Number
    K760145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Oxford Laboratories, Inc.
    Date Received
    June 29, 1976
    Decision Date
    July 19, 1976
    Product Code
    DEW
    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
    DEW Igg, Antigen, Antiserum, Control

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    Other Clearances by Oxford Laboratories, Inc.

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    K760143 SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
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    K760144 SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID
    K760146 SERUM, IGA GOAT ANTI-HUMAN ACID
    K760148 SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN