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

    VALIDATE D-Dimer Calibration Verification/Linearity Test Kit

    K Number: K152961 · Decision Jun 3, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    98
    Applicant Total
    7
    Review Days
    240

    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
    VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
    K Number
    K152961
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maine Standards Company, LLC
    Date Received
    October 7, 2015
    Decision Date
    June 3, 2016
    Product Code
    GGN
    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
    GGN Plasma, Coagulation Control

    Similar 510(k) Clearances

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

    VALIDATE D-Dimer Calibration Verification / Linearity Test Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    VALIDATE Heparin Calibration Verification/Linearity Test Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    George King Coumadin Plasma

    FDA 510(k)
    FDA Class 2 ·Hematology

    VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

    FDA 510(k)
    FDA Class 2 ·Hematology

    VisuCon-F Low Fibrinogen Control Plasma

    FDA 510(k)
    FDA Class 2 ·Hematology

    POOL NORM

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

    Other Clearances by Maine Standards Company, LLC

    K Number Device Name
    K170864 VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
    K163498 VALIDATE Heparin Calibration Verification/Linearity Test Kit
    K162705 VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
    K142964 VALIDATE Anemia Calibration Verification/ Linearity Test Kit
    K133550 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
    K110880 VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT