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

    IMMU-TEC

    K Number: K841862 · Decision Jun 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    125
    Applicant Total
    7
    Review Days
    40

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    Basic Information

    Device Name
    IMMU-TEC
    K Number
    K841862
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5270
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Medilab Corp.
    Date Received
    May 4, 1984
    Decision Date
    June 13, 1984
    Product Code
    DCK
    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
    DCK C-Reactive Protein, Antigen, Antiserum, And Control

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    Other Clearances by Medilab Corp.

    K Number Device Name
    K841863 MONO-TEC
    K840291 MCS ALBUMIN REAGENT
    K840290 MCS TOTAL PROTEIN REAGENT
    K840289 LYSE-TEC
    K832918 PREGNA-TEC
    K832527 PREGNA-TEC