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

    HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103

    K Number: K021622 · Decision Apr 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    5
    Review Days
    320

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    Basic Information

    Device Name
    HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
    K Number
    K021622
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1113
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hill-Rom Air-Shields
    Date Received
    May 16, 2002
    Decision Date
    April 1, 2003
    Product Code
    MQM
    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
    MQM Bilirubin (Total And Unbound) In The Neonate Test System

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