BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    PAR(TM) BRAND DRUG OF ABUSE CONTROLS

    K Number: K880152 · Decision May 31, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    107
    Review Days
    139

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    Basic Information

    Device Name
    PAR(TM) BRAND DRUG OF ABUSE CONTROLS
    K Number
    K880152
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Medical Analysis Systems, Inc.
    Date Received
    January 13, 1988
    Decision Date
    May 31, 1988
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DIF Drug Mixture Control Materials

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    Other Clearances by Medical Analysis Systems, Inc.

    K Number Device Name
    K042717 MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL
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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. →