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

    8000 SERIES GAS CHROMATOGRAPHS

    K Number: K872122 · Decision Jun 17, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    62
    Review Days
    15

    Basic Information

    Device Name
    8000 SERIES GAS CHROMATOGRAPHS
    K Number
    K872122
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2250
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    THE PERKIN-ELMER CORP.
    Date Received
    June 2, 1987
    Decision Date
    June 17, 1987
    Product Code
    KZQ
    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
    KZQ Chromatography(Gas), Clinical Use

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