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

    REFLAB SYSTEM PACK LIQUID CO2 REAGENT

    K Number: K926320 · Decision Feb 3, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    5
    Applicant Total
    107
    Review Days
    50

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    Basic Information

    Device Name
    REFLAB SYSTEM PACK LIQUID CO2 REAGENT
    K Number
    K926320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1160
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    December 15, 1992
    Decision Date
    February 3, 1993
    Product Code
    CHS
    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
    CHS Coulometric Method, Carbon-Dioxide

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    K032826 MAS PAR TDM
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    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. →