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

    CHARISE CHARLES REAGENT BLOOD STRIPS

    K Number: K893894 · Decision Jul 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    46
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    CHARISE CHARLES REAGENT BLOOD STRIPS
    K Number
    K893894
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.6550
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Lee Import Domestic Consulting
    Date Received
    May 30, 1989
    Decision Date
    July 27, 1989
    Product Code
    JIO
    Advisory Committee
    Hematology
    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
    JIO Blood, Occult, Colorimetric, In Urine

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    Other Clearances by Lee Import Domestic Consulting

    K Number Device Name
    K895282 CHARISE CHARLES REAGENT STRIPS