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

    CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET

    K Number: K852461 · Decision Jul 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    244
    Applicant Total
    107
    Review Days
    32

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    Basic Information

    Device Name
    CHEMTRAK LIQUID MULTI-ANALYTE CALIBRATOR, MUL-SET
    K Number
    K852461
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1150
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    June 10, 1985
    Decision Date
    July 12, 1985
    Product Code
    JIT
    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
    JIT Calibrator, Secondary

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    Other Clearances by Medical Analysis Systems, Inc.

    K Number Device Name
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    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. →