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

    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970

    K Number: DEN040002 · Decision Aug 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    1
    Review Days
    53

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970
    K Number
    DEN040002
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    862.1055
    Medical Specialty
    Clinical Chemistry
    Decision
    Unknown
    Applicant
    Perkinelmer Life Sciences, Inc.
    Date Received
    July 2, 2004
    Decision Date
    August 24, 2004
    Product Code
    NQL
    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
    NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NQL), ordered by most recent decision date.

    NeoBase 2 Non-derivatized MSMS Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NeoBase 2 Non-derivatized MSMS Kit

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    NEOBASE NON-DERIVATIZED MSMS KIT, MODEL 3040

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all