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

    GOAT ANTI-HUMAN IGM

    K Number: K802177 · Decision Oct 31, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    32
    Applicant Total
    6
    Review Days
    52

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    Basic Information

    Device Name
    GOAT ANTI-HUMAN IGM
    K Number
    K802177
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5550
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Protos Laboratories
    Date Received
    September 9, 1980
    Decision Date
    October 31, 1980
    Product Code
    DFT
    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
    DFT Igm, Antigen, Antiserum, Control

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    Other Clearances by Protos Laboratories

    K Number Device Name
    K802257 GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC
    K802196 GOAT ANTI-HUMAN COMPLEMENT C4
    K791560 GOAT ANTI-HUMAN C-REACTIVE PROTEIN
    K791605 GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
    K791115 GOAR ANTI-HUMAN LAMBODA CHAIN