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510(k) Data Aggregation

    K Number
    K002174
    Device Name
    DOCUMENT ASSAYED CHEMISTRY CONTROL, LEVELS 1, 2 AND3
    Manufacturer
    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)
    Date Cleared
    2000-08-22

    (34 days)

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

    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993014
    Device Name
    MODIFICATION TO DOCUMENT THYROID CAL.VER
    Manufacturer
    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)
    Date Cleared
    1999-11-26

    (79 days)

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

    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.
    Device Description
    DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.
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    K Number
    K992034
    Device Name
    DOCUMENT THYROID CAL*VER
    Manufacturer
    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)
    Date Cleared
    1999-07-23

    (37 days)

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

    CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical ana volificalled on the following analytes: Thyroxine (T4), Triiodothyronine (T3) and Thyroid Stimulating Hormone (TSH).
    Device Description
    DOCUMENT Thyroid CAL • VER contains assayed solutions of the following analytes: Thyroxine (T4), Trilodothyronine (T3) and Thyroid Stimulating Hormone (TSH) in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. d Thyroid CAL • VER contains 8 levels, 1 bottle per level, 5.0 millliters per bottle.
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