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

    VENTRESCREEN HCG URINE

    K Number: K853748 · Decision Oct 1, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    374
    Applicant Total
    8
    Review Days
    22

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    Basic Information

    Device Name
    VENTRESCREEN HCG URINE
    K Number
    K853748
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Vxr, Inc.
    Date Received
    September 9, 1985
    Decision Date
    October 1, 1985
    Product Code
    JHI
    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
    JHI Visual, Pregnancy Hcg, Prescription Use

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    Other Clearances by Vxr, Inc.

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    K840473 VENTREZYME T4 IMMUNOASSAY T4
    K833960 VENTREX PREGNANCY TEST KIT ENZYME
    K833989 VENTREZYME THEOPHYLLINE IMMUNOASSAY
    K833878 VENTREZYME DIGOXIN IMMUNOASSAY DIGOX
    K833909 VENTRESCREEN BETA-HCG ENZYME IMMUNO