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

    AMYLASE REAGENT SET

    K Number: K790797 · Decision Jul 17, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    5
    Review Days
    84

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    Basic Information

    Device Name
    AMYLASE REAGENT SET
    K Number
    K790797
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Alta Diagnostics, Inc.
    Date Received
    April 24, 1979
    Decision Date
    July 17, 1979
    Product Code
    KHM
    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
    KHM Nephelometric, Amylase

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    Other Clearances by Alta Diagnostics, Inc.

    K Number Device Name
    K800327 MAGNESIUM REAGENT
    K792545 URIC ACID KIT
    K792546 FETAL CHECK
    K790796 LIPASE REAGENT SET