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

    SMS, SCREEN MACHINE SYSTEM

    K Number: K852240 · Decision Jun 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    13
    Applicant Total
    2
    Review Days
    19

    Basic Information

    Device Name
    SMS, SCREEN MACHINE SYSTEM
    K Number
    K852240
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.4520
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    PANDEX LABORATORIES, INC.
    Date Received
    May 23, 1985
    Decision Date
    June 11, 1985
    Product Code
    JZT
    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
    JZT Fluorometer

    Similar 510(k) Clearances

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

    ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER

    FDA 510(k)
    FDA Class 1 ·Immunology

    QLIA IMMUNOCHEMISTRY SYSTEM

    FDA 510(k)
    FDA Class 1 ·Immunology

    STAT-20 FLUOROMETER

    FDA 510(k)
    FDA Class 1 ·Immunology

    FLUORESCENCE CONCENTRATION ANALYZER (FCA)

    FDA 510(k)
    FDA Class 1 ·Immunology

    THE FIAX 5000 FLUOROMETER

    FDA 510(k)
    FDA Class 1 ·Immunology

    PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM

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

    Other Clearances by PANDEX LABORATORIES, INC.

    K Number Device Name
    K864699 FLUORESCENCE CONCENTRATION ANALYZER (FCA)