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

    SICKLE-HEME A/S HETEROZYGOUS CONTROL

    K Number: K842955 · Decision Aug 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    3
    Review Days
    13

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    Basic Information

    Device Name
    SICKLE-HEME A/S HETEROZYGOUS CONTROL
    K Number
    K842955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Michclone Associates, Inc.
    Date Received
    July 27, 1984
    Decision Date
    August 9, 1984
    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
    K871676 ENZYMATIC CHOLESTEROL REAGENT SET
    K860812 SICKLE CELL REAGENT SET