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

    BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

    K Number: K994438 · Decision Feb 4, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    16
    Applicant Total
    2
    Review Days
    36

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    Basic Information

    Device Name
    BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
    K Number
    K994438
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1113
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spectrx, Inc.
    Date Received
    December 30, 1999
    Decision Date
    February 4, 2000
    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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