LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K121759
    Device Name
    CONE-TROL LIQUID CHEMISTRY CONTROLS
    Manufacturer
    CONE BIOPRODUCTS
    Date Cleared
    2012-07-24

    (39 days)

    Product Code
    JJY, CLA
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONE BIOPRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
    Device Description
    CONE-TROL Liquid Chemistry Control is prepared from human serum to which purified biochemical material (human and animal origin), chemicals, drugs, preservatives, and stabilizers have been added. The control is provided in liquid form for user convenience.
    Ask a Question
    K Number
    K121534
    Device Name
    CONE-TROL HEMOGLOBIN A1C CONTROL SET
    Manufacturer
    CONE BIOPRODUCTS
    Date Cleared
    2012-06-20

    (27 days)

    Product Code
    JJX, REG
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONE BIOPRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1 c determination methods.
    Device Description
    The CONE-TROL Hemoglobin A 1c Control Set is prepared from human blood to which chemicals, preservatives, and stabilizers are added. The control is provided in liquid form for user convenience.
    Ask a Question
    K Number
    K052010
    Device Name
    HBA1C LINEARITY SET
    Manufacturer
    CONE BIOPRODUCTS
    Date Cleared
    2005-10-04

    (71 days)

    Product Code
    JJX, REG
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONE BIOPRODUCTS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hemoglobin Alc Linearity is intended for use as quality control material to demonstrate linearity throughout the reportable range of Hemoglobin A1c (HbA1c%) for Immunoassay and HPLC test methods using protocols established in individual laboratories.
    Device Description
    The HbAIc Linearity Set is prepared from human blood to which stabilizers are added. The control is provided in liquid form for user convenience.
    Ask a Question

    Page 1 of 1