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

    CARTRIDGE HOLDER, RCM 100

    K Number: K782175 · Decision Feb 15, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    24
    Applicant Total
    16
    Review Days
    49

    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
    CARTRIDGE HOLDER, RCM 100
    K Number
    K782175
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Waters Assoc., Inc.
    Date Received
    December 28, 1978
    Decision Date
    February 15, 1979
    Product Code
    KIE
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KIE Apparatus, High Pressure Liquid Chromatography

    Similar 510(k) Clearances

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

    WATERS 515 HPLC PUMP (515)

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WATERS(TM) 996 PDA

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CHROMATOGRAPHY CLINICAL USE 75JQR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    EQUIPMENT/MATERIAL DECONTAMINATING KIT

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry
    View all

    Other Clearances by Waters Assoc., Inc.

    K Number Device Name
    K811975 MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL
    K802481 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH
    K801852 MRM-2 OXYGEN CONSUMPTION MONITOR
    K801431 PAN-AM MYELOGRAM TRAY
    K791661 SYSTEM CONTROLLER 720 SERIES
    K791026 4F STERILE BALLOON-LESS, CATHETER 913-28
    K790145 SOLVENT DELIVERY SYSTEM
    K781805 CARDIAC COMPUTERS, CO-10 & CO-10R
    K781915 DATA MODULE
    K781692 CALIBRATOR, DYNAMIC
    Search all 16 clearances from Waters Assoc., Inc. →