BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    NEOLYNX SCREENING APPLICATION MANAGER

    K Number: K003584 · Decision Mar 19, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    119

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    Basic Information

    Device Name
    NEOLYNX SCREENING APPLICATION MANAGER
    K Number
    K003584
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1555
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micromass, Inc.
    Date Received
    November 20, 2000
    Decision Date
    March 19, 2001
    Product Code
    JNB
    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
    JNB Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

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