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

    KENLOR HUMAN SPINAL FLUID CONTROL LIQUID

    K Number: K890576 · Decision Mar 9, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    9
    Review Days
    31

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    Basic Information

    Device Name
    KENLOR HUMAN SPINAL FLUID CONTROL LIQUID
    K Number
    K890576
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Kenlor Industries, Inc.
    Date Received
    February 6, 1989
    Decision Date
    March 9, 1989
    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 Kenlor Industries, Inc.

    K Number Device Name
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    K950326 KENLOR HUMAN SPINAL FLUID CONTROL
    K903338 KENLOR THERAPEUTIC DRUG MONITORING (TDM) CONTROL
    K896440 KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
    K890618 COOMASSIE BLUE TOTAL PROTEIN ASSAY KIT
    K890573 KENLOR TOTAL IRON, UIBC/TIBC ASSAY KIT
    K890577 KENLOR LIQUID URINE CONTROL