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

    REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175

    K Number: K900251 · Decision Feb 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    28
    Applicant Total
    280
    Review Days
    40

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    Basic Information

    Device Name
    REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
    K Number
    K900251
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1630
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    January 17, 1990
    Decision Date
    February 26, 1990
    Product Code
    CEF
    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
    CEF Electrophoretic, Protein Fractionation

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