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

    LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW

    K Number: K881990 · Decision Jun 20, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    201
    Applicant Total
    318
    Review Days
    39

    Basic Information

    Device Name
    LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW
    K Number
    K881990
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    BIO-RAD
    Date Received
    May 12, 1988
    Decision Date
    June 20, 1988
    Product Code
    DIF
    Advisory Committee
    Clinical Toxicology
    Review Advisory Committee
    TX
    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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