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

    VENTREZYME THEOPHYLLINE IMMUNOASSAY

    K Number: K833989 · Decision Jan 30, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    70
    Applicant Total
    8
    Review Days
    73

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    Basic Information

    Device Name
    VENTREZYME THEOPHYLLINE IMMUNOASSAY
    K Number
    K833989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3880
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Vxr, Inc.
    Date Received
    November 18, 1983
    Decision Date
    January 30, 1984
    Product Code
    KLS
    Advisory Committee
    Clinical Toxicology
    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
    KLS Enzyme Immunoassay, Theophylline

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    Other Clearances by Vxr, Inc.

    K Number Device Name
    K853703 VENTREZYME T3 IMMUNOASSAY T3
    K853748 VENTRESCREEN HCG URINE
    K841456 VENTREXYME EIA CONTROLS IMMUNOASSAY
    K840473 VENTREZYME T4 IMMUNOASSAY T4
    K833960 VENTREX PREGNANCY TEST KIT ENZYME
    K833878 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
    K833909 VENTRESCREEN BETA-HCG ENZYME IMMUNO