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

    AMYLASE SR LIQUID STABLE REAGENT SET

    K Number: K862733 · Decision Sep 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    98
    Applicant Total
    107
    Review Days
    73

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    Basic Information

    Device Name
    AMYLASE SR LIQUID STABLE REAGENT SET
    K Number
    K862733
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1070
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    July 18, 1986
    Decision Date
    September 29, 1986
    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 Medical Analysis Systems, Inc.

    K Number Device Name
    K042717 MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
    K041194 ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H
    K040880 MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3
    K032826 MAS PAR TDM
    K032335 MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL
    K031890 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL
    K031441 URICHEMTRAK LIQUID ASSAYED URINE CONTROL
    K031392 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL
    K031364 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3
    K030942 MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL
    Search all 107 clearances from Medical Analysis Systems, Inc. →