BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DU PONT VISTA(R) IMMUNOASSAY SYSTEM

    K Number: K900245 · Decision Apr 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    257
    Applicant Total
    253
    Review Days
    84

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    Basic Information

    Device Name
    DU PONT VISTA(R) IMMUNOASSAY SYSTEM
    K Number
    K900245
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    January 17, 1990
    Decision Date
    April 11, 1990
    Product Code
    JJQ
    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
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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