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

    LIQUID CHROMATOGRAPH 400

    K Number: K843568 · Decision Nov 20, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    14
    Applicant Total
    62
    Review Days
    71

    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
    LIQUID CHROMATOGRAPH 400
    K Number
    K843568
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2260
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    The Perkin-Elmer Corp.
    Date Received
    September 10, 1984
    Decision Date
    November 20, 1984
    Product Code
    KZR
    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
    KZR Chromatography (Liquid, Gel), Clinical Use

    Similar 510(k) Clearances

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

    2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COLUMNS LIQUID CHROMATOGRAPHY DPM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SYVA SOLID PHASE COLUMNS SYSTEM II

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    SERIES 410 LC PUMP

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    VARIAN AASP AUTOMATED SAMPLE PREP. SYSTEM

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

    Other Clearances by The Perkin-Elmer Corp.

    K Number Device Name
    K935666 PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP
    K900828 PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.
    K884864 PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO
    K884886 MODEL 250 LIQUID CHROMOTAGRAPHY PUMP
    K872737 PERKIN-ELMER LC235 DIODE ARRAY DETECTOR
    K872464 ION TRAP DETECTOR (ITD)
    K871550 PFI-20 POLARIZING FLUORIMETER
    K872122 8000 SERIES GAS CHROMATOGRAPHS
    K870661 LIFEWATCH PLUS
    K862605 MODULAR MASS SPECTROMETER (M.S.)
    Search all 62 clearances from The Perkin-Elmer Corp. →