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

    NMS 1043 ENZYME IMMUNOASSAY KIT

    K Number: K842499 · Decision Sep 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    9
    Review Days
    80

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    Basic Information

    Device Name
    NMS 1043 ENZYME IMMUNOASSAY KIT
    K Number
    K842499
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nms Pharmaceuticals, Inc.
    Date Received
    June 26, 1984
    Decision Date
    September 14, 1984
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Nms Pharmaceuticals, Inc.

    K Number Device Name
    K861202 TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS
    K854236 HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS
    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
    K850787 SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY