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

    CHEM CHEX THEOPHYLLINE CONTROL

    K Number: K920223 · Decision Jun 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    70
    Review Days
    145

    Basic Information

    Device Name
    CHEM CHEX THEOPHYLLINE CONTROL
    K Number
    K920223
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    STRECK LABORATORIES, INC.
    Date Received
    January 17, 1992
    Decision Date
    June 10, 1992
    Product Code
    LAW
    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
    LAW Theophylline Control Materials

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