LogoFDA 510(k) Search
Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K072257
    Device Name
    MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    2008-01-30

    (170 days)

    Product Code
    LAS
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K050125
    Device Name
    RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    2005-03-18

    (58 days)

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

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of control material to estimate test precision in a test system and to detect systematic deviation that may arise from reagent or analytical instrument variation in the measurement of cyclosporine A, tacrolimus and rapamycin.
    Device Description
    Not Found
    Ask a Question
    K Number
    K982845
    Device Name
    CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    1998-08-21

    (9 days)

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

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
    Device Description
    Not Found
    Ask a Question
    K Number
    K980331
    Device Name
    IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    1998-03-16

    (47 days)

    Product Code
    DIF, MKW
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviation that may arise from reagent or analytical instrument in the measurement of cyclosporin A and tacrolimus.
    Device Description
    Not Found
    Ask a Question
    K Number
    K972976
    Device Name
    CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    1997-08-29

    (18 days)

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

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The use of control material is necessary to estimate test precision in a test system and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation.
    Device Description
    CARDIAC MARKERS CONTROL (THREE LEVELS)
    Ask a Question
    K Number
    K970778
    Device Name
    LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4
    Manufacturer
    MORE DIAGNOSTICS
    Date Cleared
    1997-04-17

    (44 days)

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

    MORE DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1