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

    RELLPLATE C KIT, RELLPLATE C BULK PLATES

    K Number: K884940 · Decision Mar 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    189
    Applicant Total
    39
    Review Days
    105

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    Basic Information

    Device Name
    RELLPLATE C KIT, RELLPLATE C BULK PLATES
    K Number
    K884940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7290
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    American Diagnostic Corp.
    Date Received
    November 28, 1988
    Decision Date
    March 13, 1989
    Product Code
    GGP
    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
    GGP Test, Qualitative And Quantitative Factor Deficiency

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