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

    REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171

    K Number: K893211 · Decision Jun 19, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    28
    Applicant Total
    280
    Review Days
    53

    Basic Information

    Device Name
    REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
    K Number
    K893211
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1630
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    HELENA LABORATORIES
    Date Received
    April 27, 1989
    Decision Date
    June 19, 1989
    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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