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

    HS-100 HEADSPACE SAMPLING ACCESSORY

    K Number: K831387 · Decision Aug 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    11
    Applicant Total
    62
    Review Days
    118

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    Basic Information

    Device Name
    HS-100 HEADSPACE SAMPLING ACCESSORY
    K Number
    K831387
    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
    April 28, 1983
    Decision Date
    August 24, 1983
    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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