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

    SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN

    K Number: K760143 · Decision Jul 20, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    9
    Review Days
    21

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    Basic Information

    Device Name
    SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMAN
    K Number
    K760143
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5420
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Oxford Laboratories, Inc.
    Date Received
    June 29, 1976
    Decision Date
    July 20, 1976
    Product Code
    DEX
    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
    DEX Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

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    Other Clearances by Oxford Laboratories, Inc.

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    K780912 ADJUSTABLE DISPENSOR
    K760078 REAGENT, RIA TRIIODOTHYRONINE T3 (#200)
    K760147 SERUM, IGM ANTI-HUMAN ACID
    K760079 REAGENT, THYROXINE T4 (#210)
    K760144 SERUM, HAPTOGLOBIN GOAT ANTI-HUMAN ACID
    K760146 SERUM, IGA GOAT ANTI-HUMAN ACID
    K760148 SERUM, B1A GLOBULIN C3C GOAT ANTI-HUMAN
    K760145 SERUM, IGG GOAT ANTI-HUMAN ACID