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

    HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE

    K Number: K895105 · Decision Oct 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    2
    Review Days
    52

    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
    HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE
    K Number
    K895105
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Waters Chemical Products
    Date Received
    August 15, 1989
    Decision Date
    October 6, 1989
    Product Code
    DPM
    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
    DPM Columns, Liquid Chromatography

    Similar 510(k) Clearances

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

    TOX PERFECT B TUBES AND REAGENTS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUID CHROMATOGRAPHY COLUMNS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ADVANCED PURIFICATION GLASS COLUMN

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    LIQUID CHROMATO. COLUMNS

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

    Other Clearances by Waters Chemical Products

    K Number Device Name
    K891673 ADVANCED PURIFICATION GLASS COLUMN