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

    RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST

    K Number: K883385 · Decision Sep 7, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    43
    Applicant Total
    7
    Review Days
    29

    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
    RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST
    K Number
    K883385
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Los Alamos Diagnostics
    Date Received
    August 9, 1988
    Decision Date
    September 7, 1988
    Product Code
    JXA
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JXA Kit, Screening, Urine

    Similar 510(k) Clearances

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

    OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    URISCREEN

    FDA 510(k)
    FDA Class 1 ·Microbiology

    URINE SCREENING DEVICE

    FDA 510(k)
    FDA Class 1 ·Microbiology

    TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MULTIPLE (IZON DBS & URINE COLLECTION KIT)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)

    FDA 510(k)
    FDA Class 1 ·Microbiology
    View all

    Other Clearances by Los Alamos Diagnostics

    K Number Device Name
    K896117 MODIFIED MODEL 535(TM) LUMINOMETER
    K882608 LAD MODEL 633 LUMINOMETER
    K881439 MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM
    K874262 LAD MODEL 735 LUMINOMETER
    K864202 UTISCREEN(R) BACTERIAL ATP TEST
    K864201 LAD MODEL 535 LUMINOMETER