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

    REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170

    K Number: K881852 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    280
    Review Days
    67

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    Basic Information

    Device Name
    REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170
    K Number
    K881852
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Helena Laboratories
    Date Received
    May 2, 1988
    Decision Date
    July 8, 1988
    Product Code
    JJN
    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
    JJN Apparatus, Electrophoresis, For Clinical Use

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