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

    ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III

    K Number: K913677 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    82
    Applicant Total
    42
    Review Days
    37

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    Basic Information

    Device Name
    ACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,III
    K Number
    K913677
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.3280
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Analytical Control Systems, Inc.
    Date Received
    August 19, 1991
    Decision Date
    September 25, 1991
    Product Code
    LAS
    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
    LAS Drug Specific Control Materials

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