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

    LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL

    K Number: K883247 · Decision Sep 13, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    8
    Review Days
    42

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    Basic Information

    Device Name
    LIPOPHOR(TM) SYST, HUMAN SERUM LIPOPROTEIN CONTROL
    K Number
    K883247
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Quantimetrix Medical Industries
    Date Received
    August 2, 1988
    Decision Date
    September 13, 1988
    Product Code
    JJY
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

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    Other Clearances by Quantimetrix Medical Industries

    K Number Device Name
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    K874302 QUANTIMETRIX TOTAL CREATINE KINASE CONTROL
    K874890 QUANTIMETRIX URINE DIPSTICK CONTROL
    K873011 QUANTIMETRIX SERUM ALCOHOL CONTROL LEVEL 1 AND 2
    K873467 QUANTIMETRIX URINE DRUGS OF ABUSE CONTROL
    K861448 QUANTIMETRIX SERUM LIPID CONTROL I & II LIQUID