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

    DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI

    K Number: K901017 · Decision May 15, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    253
    Review Days
    71

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    Basic Information

    Device Name
    DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI
    K Number
    K901017
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    March 5, 1990
    Decision Date
    May 15, 1990
    Product Code
    JFJ
    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
    JFJ Catalytic Methods, Amylase

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