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

    NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265

    K Number: K073537 · Decision Jun 27, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    11
    Review Days
    193

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    Basic Information

    Device Name
    NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265
    K Number
    K073537
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1113
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Siemens Medical Solutions Diagnostics
    Date Received
    December 17, 2007
    Decision Date
    June 27, 2008
    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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