BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SODIUM CHLORIDE SOLUTION BLOOD CELL

    K Number: K841183 · Decision May 21, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    1
    Applicant Total
    19
    Review Days
    62

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    Basic Information

    Device Name
    SODIUM CHLORIDE SOLUTION BLOOD CELL
    K Number
    K841183
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Reagent Laboratory, Inc.
    Date Received
    March 20, 1984
    Decision Date
    May 21, 1984
    Product Code
    FNW
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FNW Pad, Kelly

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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
    K841847 LITHIUM REAGENT
    K843051 WRIGHTS STAIN SOLUTION
    K841799 CYANOMETHEMOGLOBIN REAGENT
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