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

    VENTREXYME EIA CONTROLS IMMUNOASSAY

    K Number: K841456 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    101
    Registration Numbers
    101
    Same Product Code
    301
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    VENTREXYME EIA CONTROLS IMMUNOASSAY
    K Number
    K841456
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Vxr, Inc.
    Date Received
    April 9, 1984
    Decision Date
    May 21, 1984
    Product Code
    JIX
    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
    JIX Calibrator, Multi-Analyte Mixture

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    K833960 VENTREX PREGNANCY TEST KIT ENZYME
    K833989 VENTREZYME THEOPHYLLINE IMMUNOASSAY
    K833878 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
    K833909 VENTRESCREEN BETA-HCG ENZYME IMMUNO