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

    340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER

    K Number: K945408 · Decision Feb 22, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    52
    Applicant Total
    41
    Review Days
    111

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    Basic Information

    Device Name
    340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER
    K Number
    K945408
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1170
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Catachem, Inc.
    Date Received
    November 3, 1994
    Decision Date
    February 22, 1995
    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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