BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CALCIUM QVET

    K Number: K943003 · Decision Dec 9, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    27
    Review Days
    169

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    Basic Information

    Device Name
    CALCIUM QVET
    K Number
    K943003
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1030
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Prisma Systems
    Date Received
    June 23, 1994
    Decision Date
    December 9, 1994
    Product Code
    CJJ
    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
    CJJ Diazo, Alt/Sgpt

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