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

    BUN REAGENT

    K Number: K040973 · Decision Dec 27, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    14
    Applicant Total
    8
    Review Days
    257

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    Basic Information

    Device Name
    BUN REAGENT
    K Number
    K040973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    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
    CDS
    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
    CDS Electrode, Ion Specific, Urea Nitrogen

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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
    K040977 GENCHEM ELECTROLYTE BUFFER
    K040975 GENCHEM CO2 ACID REAGENT
    K040976 GENCHEM CREATININE REAGENT
    K040972 CALCIUM, AZO DYE REAGENT
    K040974 GLUCOSE OXIDASE, GLUCOSE
    K040971 GENCHEM ISE ELECTROLYTE REFERENCE