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510(k) Data Aggregation

    K Number
    K983304
    Device Name
    SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT
    Manufacturer
    SYNERMED INTL., INC.
    Date Cleared
    1998-11-04

    (44 days)

    Product Code
    CIG
    Regulation Number
    862.1110
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
    Device Description
    Direct Bilirubin Reagent Kit
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    K Number
    K974909
    Device Name
    SYNERMED CREATININE REAGENT KIT
    Manufacturer
    SYNERMED INTL., INC.
    Date Cleared
    1998-02-24

    (55 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYNERMED INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods.
    Device Description
    Creatinine Reagent kit
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