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

    SICKLE CELL REAGENT SET

    K Number: K811828 · Decision Aug 12, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    17
    Applicant Total
    26
    Review Days
    44

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    Basic Information

    Device Name
    SICKLE CELL REAGENT SET
    K Number
    K811828
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.7825
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Applicant
    Anco Medical Reagents & Assoc.
    Date Received
    June 29, 1981
    Decision Date
    August 12, 1981
    Product Code
    GHM
    Advisory Committee
    Hematology
    Review Advisory Committee
    CH
    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 Anco Medical Reagents & Assoc.

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    K821526 ACID PHOSPHATASE REAGENT SET
    K821102 MEGNESIUM REAGENT KIT
    K820951 ENZYMATIC CHOLESTEROL KIT
    K820491 SGPT REAGENT SET
    K820500 TOTAL LIPID REAGENT SET
    K820466 SGOT REAGENT SET
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