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

    SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY

    K Number: K850787 · Decision Mar 26, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    41
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY
    K Number
    K850787
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1265
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nms Pharmaceuticals, Inc.
    Date Received
    February 26, 1985
    Decision Date
    March 26, 1985
    Product Code
    CGI
    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
    CGI Radioimmunoassay, Estriol

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    Other Clearances by Nms Pharmaceuticals, Inc.

    K Number Device Name
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    K860828 FORETEL, COLOR OVULATION TEST
    K853925 QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA
    K851445 COLOR OVULATION TEST
    K850431 EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL
    K850786 TOTAL HIGE ENZYME IMMUNOASSAY
    K842499 NMS 1043 ENZYME IMMUNOASSAY KIT