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

    SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT

    K Number: K041643 · Decision Aug 18, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    38
    Registration Numbers
    38
    Same Product Code
    104
    Applicant Total
    270
    Review Days
    62

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    Basic Information

    Device Name
    SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
    K Number
    K041643
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1580
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Beckman Coulter, Inc.
    Date Received
    June 17, 2004
    Decision Date
    August 18, 2004
    Product Code
    CEO
    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
    CEO Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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