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

    ROTOR SYSTEMS A/S-400 & LA/S-400

    K Number: K850485 · Decision Mar 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    253
    Review Days
    33

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    Basic Information

    Device Name
    ROTOR SYSTEMS A/S-400 & LA/S-400
    K Number
    K850485
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    E.I. Dupont DE Nemours & Co., Inc.
    Date Received
    February 7, 1985
    Decision Date
    March 12, 1985
    Product Code
    JQC
    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
    JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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