BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT

    K Number: K110880 · Decision Jul 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Same Product Code
    672
    Applicant Total
    7
    Review Days
    97

    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 (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT
    K Number
    K110880
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1660
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Maine Standards Company, LLC
    Date Received
    March 30, 2011
    Decision Date
    July 5, 2011
    Product Code
    JJY
    Advisory Committee
    Clinical Chemistry
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    Similar 510(k) Clearances

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

    Multichem IA Plus

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Audit MicroControls Linearity FD Tumor Markers II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Liquichek Cardiac Markers Plus Control LT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VALIDATE Anemia Calibration Verification/ Linearity Test Kit

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    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
    K152961 VALIDATE D-Dimer Calibration Verification/Linearity Test Kit
    K142964 VALIDATE Anemia Calibration Verification/ Linearity Test Kit
    K133550 VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT