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

    GOAR ANTI-HUMAN LAMBODA CHAIN

    K Number: K791115 · Decision Aug 3, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    52
    Applicant Total
    6
    Review Days
    49

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    Basic Information

    Device Name
    GOAR ANTI-HUMAN LAMBODA CHAIN
    K Number
    K791115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Protos Laboratories
    Date Received
    June 15, 1979
    Decision Date
    August 3, 1979
    Product Code
    DEH
    Advisory Committee
    Immunology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DEH Lambda, Antigen, Antiserum, Control

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    Other Clearances by Protos Laboratories

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    K791560 GOAT ANTI-HUMAN C-REACTIVE PROTEIN
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