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510(k) Data Aggregation

    K Number
    K982298
    Device Name
    OPTICOAT T4 EIA KIT
    Manufacturer
    BIOTECX LABORATORIES, INC.
    Date Cleared
    1999-02-03

    (217 days)

    Product Code
    KLI
    Regulation Number
    862.1700
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTECX LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
    Device Description
    Not Found
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    K Number
    K981824
    Device Name
    OPTICOAT T3 EIA KIT
    Manufacturer
    BIOTECX LABORATORIES, INC.
    Date Cleared
    1998-12-22

    (214 days)

    Product Code
    CDP
    Regulation Number
    862.1710
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTECX LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
    Device Description
    Not Found
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