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

    BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE

    K Number: K914202 · Decision Oct 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    257
    Applicant Total
    72
    Review Days
    22

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    Basic Information

    Device Name
    BARTELS PRIMA SYSTEM ADVANCED SCREENING CARTRIDGE
    K Number
    K914202
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2300
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Diagnostics, Inc.
    Date Received
    September 19, 1991
    Decision Date
    October 11, 1991
    Product Code
    JJQ
    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
    JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

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