BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    TAGO FIFFU-GEN, OROSOMUCOID

    K Number: K841734 · Decision Jun 1, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    10
    Applicant Total
    8
    Review Days
    36

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    Basic Information

    Device Name
    TAGO FIFFU-GEN, OROSOMUCOID
    K Number
    K841734
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.5420
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Tago, Inc.
    Date Received
    April 26, 1984
    Decision Date
    June 1, 1984
    Product Code
    LKL
    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
    LKL Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control

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    Other Clearances by Tago, Inc.

    K Number Device Name
    K841265 TAGO DIFFU-GEN C-REACTIVE PROTEIN
    K834218 DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
    K840404 DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
    K833129 TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
    K830611 RA SCREENING TEST
    K830531 MONO SCREENING TEST
    K830156 HCG SCREENING TEST