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

    TAGO DIFFU-GEN-APOLIPOPROTEIN B-100

    K Number: K833129 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    49
    Applicant Total
    8
    Review Days
    69

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    Basic Information

    Device Name
    TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
    K Number
    K833129
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1475
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Tago, Inc.
    Date Received
    September 13, 1983
    Decision Date
    November 21, 1983
    Product Code
    MSJ
    Advisory Committee
    Clinical Chemistry
    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
    MSJ Apolipoproteins

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    Other Clearances by Tago, Inc.

    K Number Device Name
    K841734 TAGO FIFFU-GEN, OROSOMUCOID
    K841265 TAGO DIFFU-GEN C-REACTIVE PROTEIN
    K834218 DIFFU-GEN APOLIPOPROTEIN A-I RADIAL -
    K840404 DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO
    K830611 RA SCREENING TEST
    K830531 MONO SCREENING TEST
    K830156 HCG SCREENING TEST