BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CLEANTECH SYSTEM

    K Number: K882539 · Decision Aug 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    15
    Review Days
    48

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    Basic Information

    Device Name
    CLEANTECH SYSTEM
    K Number
    K882539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Schiff & Co.
    Date Received
    June 21, 1988
    Decision Date
    August 8, 1988
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    K974141 PLUS REUSABLE RESUSCITATOR
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    K955085 HM-CAP EIA TEST (MODIFICATION)
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