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

    TEST, STREP, LATEX SLIDE

    K Number: K760034 · Decision Aug 11, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    29
    Applicant Total
    21
    Review Days
    58

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    Basic Information

    Device Name
    TEST, STREP, LATEX SLIDE
    K Number
    K760034
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5130
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Gamma Biologicals, Inc.
    Date Received
    June 14, 1976
    Decision Date
    August 11, 1976
    Product Code
    DEM
    Advisory Committee
    Immunology
    Review Advisory Committee
    MI
    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

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