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

    VENTREZYME PHENOBARBITAL KIT IMMUNO

    K Number: K842264 · Decision Aug 14, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    34
    Applicant Total
    82
    Review Days
    68

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    Basic Information

    Device Name
    VENTREZYME PHENOBARBITAL KIT IMMUNO
    K Number
    K842264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3660
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Ventrex Laboratories, Inc.
    Date Received
    June 7, 1984
    Decision Date
    August 14, 1984
    Product Code
    DLZ
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DLZ Enzyme Immunoassay, Phenobarbital

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    Other Clearances by Ventrex Laboratories, Inc.

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    K905612 VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
    K905636 VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
    K905247 SHBG IRMA KIT
    K904330 TURBO-RAST SPECIFIC IGE ASSAY
    K903000 TURBO-RAST SPECIFIC IGE ASSAY
    K897083 VENTRESIGN STREP A TEST
    K895648 COATED TUBE HIGH SENSITIVITY TSH 100 UIU/ML STAN.
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