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

    VENTRESCREEN BETA-HCG ENZYME IMMUNO

    K Number: K833909 · Decision Nov 21, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    115
    Applicant Total
    8
    Review Days
    7

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    Basic Information

    Device Name
    VENTRESCREEN BETA-HCG ENZYME IMMUNO
    K Number
    K833909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3880
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Vxr, Inc.
    Date Received
    November 14, 1983
    Decision Date
    November 21, 1983
    Product Code
    ETD
    Advisory Committee
    Ear, Nose, Throat
    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
    ETD Tube, Tympanostomy

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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
    K833989 VENTREZYME THEOPHYLLINE IMMUNOASSAY
    K833878 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX