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

    REAGENT, CHLORIDE, COULTER

    K Number: K770752 · Decision Jun 17, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    52
    Applicant Total
    101
    Review Days
    53

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    Basic Information

    Device Name
    REAGENT, CHLORIDE, COULTER
    K Number
    K770752
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Coulter Electronics, Inc.
    Date Received
    April 25, 1977
    Decision Date
    June 17, 1977
    Product Code
    CHJ
    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
    CHJ Mercuric Thiocyanate, Colorimetry, Chloride

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