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

    FREND PSA PLUS (reagent cartridge)

    K Number: K162378 · Decision May 17, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    33
    Applicant Total
    5
    Review Days
    266

    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
    FREND PSA PLUS (reagent cartridge)
    K Number
    K162378
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nanoentek USA, Inc.
    Date Received
    August 24, 2016
    Decision Date
    May 17, 2017
    Product Code
    LTJ
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

    Similar 510(k) Clearances

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

    Atellica IM Total PSA II (tPSAII)

    FDA 510(k)
    FDA Class 2 ·Immunology

    FREND PSA PLUS (REAGENT CARTRIDGE)

    FDA 510(k)
    FDA Class 2 ·Immunology

    TPSA FLEX REAGENT CARTRIDGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428

    FDA 510(k)
    FDA Class 2 ·Immunology
    View all

    Other Clearances by Nanoentek USA, Inc.

    K Number Device Name
    K162754 FREND Vitamin D Test System
    K153577 FREND Testosterone Test System
    K152422 FREND™ Free T4 Test System
    K131928 FREND TSH (REAGENT CARTRIDGE)