BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    GENCHEM CREATININE REAGENT

    K Number: K040976 · Decision Dec 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    158
    Applicant Total
    8
    Review Days
    257

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    Basic Information

    Device Name
    GENCHEM CREATININE REAGENT
    K Number
    K040976
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1225
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genchem, Inc.
    Date Received
    April 14, 2004
    Decision Date
    December 27, 2004
    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 Genchem, Inc.

    K Number Device Name
    K090283 CALIBRATOR 1,2, AND 3 MODELS: GEN-CAL1, GEN-CAL2, AND GEN-CAL3
    K040973 BUN REAGENT
    K040977 GENCHEM ELECTROLYTE BUFFER
    K040975 GENCHEM CO2 ACID REAGENT
    K040972 CALCIUM, AZO DYE REAGENT
    K040974 GLUCOSE OXIDASE, GLUCOSE
    K040971 GENCHEM ISE ELECTROLYTE REFERENCE