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

    R&D SICKLE QC CONTROL

    K Number: K070334 · Decision Mar 29, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    14
    Applicant Total
    79
    Review Days
    52

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    R&D SICKLE QC CONTROL
    K Number
    K070334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.8625
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    R&D Systems, Inc.
    Date Received
    February 5, 2007
    Decision Date
    March 29, 2007
    Product Code
    GGM
    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
    GGM Control, Hemoglobin

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GGM), ordered by most recent decision date.

    HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High

    FDA 510(k)
    FDA Class 2 ·Hematology

    HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High

    FDA 510(k)
    FDA Class 2 ·Hematology

    LYPHOCHEK DIABETES CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4

    FDA 510(k)
    FDA Class 2 ·Hematology

    GLYCOHEMOSURE HBA1C CONTROL

    FDA 510(k)
    FDA Class 2 ·Hematology

    LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET

    FDA 510(k)
    FDA Class 2 ·Hematology
    View all

    Other Clearances by R&D Systems, Inc.

    K Number Device Name
    K160606 BC-5D Hematology Control
    K130962 R&D 5D RETIC HEMATOLOGY CONTROL
    K101578 R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
    K100050 R & D SYSTEMS XERET HEMATOLOGY CONTROL
    K091433 R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
    K073178 HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
    K072846 CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
    K072268 HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
    K072096 CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
    K061511 R&D CBC-3D + CRP HEMATOLOGY CONTROL
    Search all 79 clearances from R&D Systems, Inc. →