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

    AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

    K Number: K951494 · Decision Dec 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    30
    Applicant Total
    62
    Review Days
    255

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    Basic Information

    Device Name
    AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
    K Number
    K951494
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emd Chemicals, Inc.
    Date Received
    March 31, 1995
    Decision Date
    December 11, 1995
    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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