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

    GEMENI URIC ACID U.V.

    K Number: K873358 · Decision Sep 11, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    30
    Applicant Total
    41
    Review Days
    21

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    Basic Information

    Device Name
    GEMENI URIC ACID U.V.
    K Number
    K873358
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1775
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics Laboratories, Inc.
    Date Received
    August 21, 1987
    Decision Date
    September 11, 1987
    Product Code
    CDO
    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
    CDO Acid, Uric, Uricase (U.V.)

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    Other Clearances by Electro-Nucleonics Laboratories, Inc.

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    K870928 CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS
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