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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    SYNERMED CREATININE REAGENT KIT

    K Number: K974909 · Decision Feb 24, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    2
    Review Days
    55

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    Basic Information

    Device Name
    SYNERMED CREATININE REAGENT KIT
    K Number
    K974909
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Synermed Intl., Inc.
    Date Received
    December 31, 1997
    Decision Date
    February 24, 1998
    Product Code
    CGX
    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
    CGX Alkaline Picrate, Colorimetry, Creatinine

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    Other Clearances by Synermed Intl., Inc.

    K Number Device Name
    K983304 SYNERMED NEAR-INFRARED DIRECT BILIRUBIN REAGENT KIT