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

    SICKLE CELL REAGENT SET

    K Number: K860812 · Decision Apr 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    38

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    Basic Information

    Device Name
    SICKLE CELL REAGENT SET
    K Number
    K860812
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Michclone Associates, Inc.
    Date Received
    March 4, 1986
    Decision Date
    April 11, 1986
    Product Code
    GHM
    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
    GHM Test, Sickle Cell

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    Other Clearances by Michclone Associates, Inc.

    K Number Device Name
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    K842955 SICKLE-HEME A/S HETEROZYGOUS CONTROL