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

    AMYLASE

    K Number: K832889 · Decision Nov 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    74
    Review Days
    95

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    Basic Information

    Device Name
    AMYLASE
    K Number
    K832889
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    August 22, 1983
    Decision Date
    November 25, 1983
    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 Pointe Scientific, Inc.,

    K Number Device Name
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    K070251 CARBON DIOXIDE LIQUID STABLE REAGENT
    K070207 MULTI-ANALYTE CHEMISTRY CALIBRATOR
    K070504 AMMONIA/ALCOHOL CONTROL SET
    K061377 APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
    K051646 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
    K040391 TOTAL BILIRUBIN REAGENT SET
    K031539 HEMOGLOBIN A1C REAGENT SET
    K023860 MICROALBUMIN REAGENT SET AND CALIBRATORS
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