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

    TOTAL HIGE ENZYME IMMUNOASSAY

    K Number: K850786 · Decision Apr 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    113
    Applicant Total
    9
    Review Days
    45

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    Basic Information

    Device Name
    TOTAL HIGE ENZYME IMMUNOASSAY
    K Number
    K850786
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5510
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    Nms Pharmaceuticals, Inc.
    Date Received
    February 26, 1985
    Decision Date
    April 12, 1985
    Product Code
    DGC
    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
    DGC Ige, Antigen, Antiserum, Control

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    K853925 QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
    K851445 COLOR OVULATION TEST
    K850431 EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
    K850787 SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
    K842499 NMS 1043 ENZYME IMMUNOASSAY KIT