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

    KINETIC AMYLASE DETERMINATION

    K Number: K905651 · Decision Jan 31, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    20
    Review Days
    44

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    Basic Information

    Device Name
    KINETIC AMYLASE DETERMINATION
    K Number
    K905651
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Biochemical Trade, Inc.
    Date Received
    December 18, 1990
    Decision Date
    January 31, 1991
    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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    Other Clearances by Biochemical Trade, Inc.

    K Number Device Name
    K942958 CREATINE KINASE MB DETERMINATION (UV)
    K910635 TOTAL BILIRUBIN REAGENT SET
    K910296 PHOSPHORUS (INORGANIC) TEST SYSTEM
    K905776 ALBUMIN REAGENT SET
    K905790 TOTAL PROTEIN REAGENT SET
    K905619 CREATININE (RATE) REAGENT SET
    K905650 KINETIC ALKALINE PHOSPHATASE DETERMINATION
    K905649 GAMMA-GLUTAMYL TRANSFERASE DETERMINATION
    K905588 CREATINE KINASE UV REAGENT SET
    K871547 ULTRA-VIOLET BUN REAGENT KIT (RATE)
    Search all 20 clearances from Biochemical Trade, Inc. →