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

    DUPONT DIMENSION AMYLASE METHOD

    K Number: K942640 · Decision Sep 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    28
    Review Days
    98

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    Basic Information

    Device Name
    DUPONT DIMENSION AMYLASE METHOD
    K Number
    K942640
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Dupont Medical Products
    Date Received
    June 3, 1994
    Decision Date
    September 9, 1994
    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 Dupont Medical Products

    K Number Device Name
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    K952816 LIPASE FLEX REAGENT CARTRIDGE
    K952412 DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROL
    K945280 DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
    K944932 PHENOBARBITAL FLEX REAGENT CARTRIDGE
    K941050 DUPONT ACA STAR
    K943996 DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD
    K941146 DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM
    K942241 DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN
    Search all 28 clearances from Dupont Medical Products →