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

    LITHIUM REAGENT

    K Number: K841847 · Decision Aug 17, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    21
    Applicant Total
    19
    Review Days
    121

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    Basic Information

    Device Name
    LITHIUM REAGENT
    K Number
    K841847
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2540
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Reagent Laboratory, Inc.
    Date Received
    April 18, 1984
    Decision Date
    August 17, 1984
    Product Code
    JJO
    Advisory Committee
    Clinical Chemistry
    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
    JJO Flame Emission Photometer For Clinical Use

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    Other Clearances by Reagent Laboratory, Inc.

    K Number Device Name
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    K860143 URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE
    K842982 FORMALIN BUFFERED
    K843050 GRAM STAIN
    K842785 STAIN, METHYLENE BLUE-EOSIN
    K843051 WRIGHTS STAIN SOLUTION
    K841799 CYANOMETHEMOGLOBIN REAGENT
    K841800 LYSING & HEMOGLOBIN REAGENT
    Search all 19 clearances from Reagent Laboratory, Inc. →