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

    FLOW-PAC ALBUMIN REAGENT

    K Number: K830536 · Decision Mar 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    119
    Applicant Total
    39
    Review Days
    34

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    Basic Information

    Device Name
    FLOW-PAC ALBUMIN REAGENT
    K Number
    K830536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1035
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Amresco, Inc.
    Date Received
    February 18, 1983
    Decision Date
    March 24, 1983
    Product Code
    CIX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

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

    Product Code Device Name
    CIX Bromcresol Green Dye-Binding, Albumin

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    Other Clearances by Amresco, Inc.

    K Number Device Name
    K905618 GGT REAGENT
    K904468 DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
    K905684 ALKALINE PHOSPHATASE
    K905544 MAGNESIUM REAGENT
    K905284 HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
    K904004 AMRESCOCREAT KINASE REAGENT 7716/17,7516,7416,7116
    K905096 GGT REAGENTS, 7738, 7739, 7538, 7438 & 7138
    K904381 DIAZO COLORIMENTRY DIRECT BILIRUBIN
    K903775 CREATINE PHOSPHOKINASE
    K903829 AST REAGENT
    Search all 39 clearances from Amresco, Inc. →