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

    SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT

    K Number: K013978 · Decision Jan 15, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    270
    Review Days
    43

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
    K Number
    K013978
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    December 3, 2001
    Decision Date
    January 15, 2002
    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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