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

    GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN

    K Number: K791605 · Decision Sep 4, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    6
    Review Days
    15

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    Basic Information

    Device Name
    GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
    K Number
    K791605
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Protos Laboratories
    Date Received
    August 20, 1979
    Decision Date
    September 4, 1979
    Product Code
    DEM
    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
    DEM Alpha-1-Antitrypsin, Antigen, Antiserum, Control

    Similar 510(k) Clearances

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    Other Clearances by Protos Laboratories

    K Number Device Name
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    K791115 GOAR ANTI-HUMAN LAMBODA CHAIN