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

    QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL

    K Number: K873467 · Decision Sep 29, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    8
    Review Days
    32

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    Basic Information

    Device Name
    QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
    K Number
    K873467
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    August 28, 1987
    Decision Date
    September 29, 1987
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    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
    DIF Drug Mixture Control Materials

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    Other Clearances by Quantimetrix Medical Industries

    K Number Device Name
    K895778 QUANTIMETRIX BILIRUBIN CALIBRATORS
    K883395 ALKPHOR(TM) SYSTEM, HUMAN SERUM ALKA PHOS ISOENZY
    K883247 LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
    K874302 QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
    K874890 QUANTIMETRIX URINE DIPSTICK CONTROL
    K873011 QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
    K861448 QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID