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

    DMA AMYLASE (DEMAND) PROCEDURE

    K Number: K940010 · Decision Mar 11, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    111
    Review Days
    66

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    Basic Information

    Device Name
    DMA AMYLASE (DEMAND) PROCEDURE
    K Number
    K940010
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Data Medical Associates, Inc.
    Date Received
    January 4, 1994
    Decision Date
    March 11, 1994
    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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    K955300 TOTAL BILIRUBIN PROCEDURE
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