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

    ULTRAZYME PLUS AMYL

    K Number: K821869 · Decision Jul 13, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    23
    Review Days
    18

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    Basic Information

    Device Name
    ULTRAZYME PLUS AMYL
    K Number
    K821869
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Harleco Diagnostics
    Date Received
    June 25, 1982
    Decision Date
    July 13, 1982
    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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    Other Clearances by Harleco Diagnostics

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    K821878 ULTRAZYME PLUS LDH
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    K821882 ULTRAZYME PLUS GPT
    K821877 ULTRAZYME PLUS HBD
    K821883 ULTRAZYME PLUS CK-I
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