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

    ELI URINE CONTROLS

    K Number: K951817 · Decision Jun 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    41
    Registration Numbers
    41
    Same Product Code
    201
    Applicant Total
    1
    Review Days
    60

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    Basic Information

    Device Name
    ELI URINE CONTROLS
    K Number
    K951817
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elsohly Labs, Inc.
    Date Received
    April 20, 1995
    Decision Date
    June 19, 1995
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    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
    DIF Drug Mixture Control Materials

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