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

    BUN

    K Number: K971967 · Decision Jun 17, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    116
    Applicant Total
    20
    Review Days
    20

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    Basic Information

    Device Name
    BUN
    K Number
    K971967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1770
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carolina Liquid Chemistries Corp.
    Date Received
    May 28, 1997
    Decision Date
    June 17, 1997
    Product Code
    CDQ
    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
    CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

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    Other Clearances by Carolina Liquid Chemistries Corp.

    K Number Device Name
    K213211 Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System
    K133519 CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
    K132711 CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
    K972073 TOTAL BILIRUBIN REAGENT
    K971907 CALCIUM REAGENT
    K971324 TRIGLYCERIDES, TG, OR TRIG
    K971908 CREA OR CREATININE
    K971467 SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
    K971345 CHOL OR CHOLESTEROL
    K971396 CK REAGENT
    Search all 20 clearances from Carolina Liquid Chemistries Corp. →