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

    PHOSPHORUS TEST ITEM NUMBER 65416

    K Number: K894288 · Decision Aug 31, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    288
    Review Days
    69

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    Basic Information

    Device Name
    PHOSPHORUS TEST ITEM NUMBER 65416
    K Number
    K894288
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1520
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Em Diagnostic Systems, Inc.
    Date Received
    June 23, 1989
    Decision Date
    August 31, 1989
    Product Code
    CED
    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
    CED 5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

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    Other Clearances by Em Diagnostic Systems, Inc.

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    K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410
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