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

    ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL

    K Number: K873250 · Decision Oct 20, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    296
    Review Days
    64

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    Basic Information

    Device Name
    ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
    K Number
    K873250
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Roche Diagnostic Systems, Inc.
    Date Received
    August 17, 1987
    Decision Date
    October 20, 1987
    Product Code
    CIJ
    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
    CIJ Saccharogenic, Amylase

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