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

    ORGENTEC MICRO-ALBUMIN EIA ASSAY

    K Number: K970932 · Decision Apr 8, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    37
    Applicant Total
    27
    Review Days
    47

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    Basic Information

    Device Name
    ORGENTEC MICRO-ALBUMIN EIA ASSAY
    K Number
    K970932
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1645
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    American Laboratory Products Co., Ltd.
    Date Received
    February 20, 1997
    Decision Date
    April 8, 1997
    Product Code
    JIR
    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
    JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)

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