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

    NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U

    K Number: K093916 · Decision Aug 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    4
    Applicant Total
    17
    Review Days
    244

    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
    NEOBASE NON-DERIVATIZED MSMS KIT MODEL 3040-001U
    K Number
    K093916
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1055
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Perkinelmer, Inc.
    Date Received
    December 22, 2009
    Decision Date
    August 23, 2010
    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

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

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

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

    Other Clearances by Perkinelmer, Inc.

    K Number Device Name
    DEN200044 Eonis SCID-SMA Kit
    K203035 Eonis SCID-SMA kit
    K193103 NeoBase 2 Non-derivatized MSMS Kit
    DEN180056 GSP Neonatal Creatine Kinase - MM kit
    K190335 GSP Neonatal Total Galactose kit
    K190266 NeoLSD MSMS Kit
    K161966 PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector
    K161942 PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector
    K142698 PerkinElmer, XRpad 4343 F MED Flat Panel Detector
    K140551 PERKINELMER, XRPAD 4336 MED FLAT PANEL DETECTOR
    Search all 17 clearances from Perkinelmer, Inc. →