BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HI-M-TEST FOR METHADONE TEST #2

    K Number: K801509 · Decision Jul 14, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    14

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    Basic Information

    Device Name
    HI-M-TEST FOR METHADONE TEST #2
    K Number
    K801509
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3620
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Applicant
    Technam, Inc.
    Date Received
    June 30, 1980
    Decision Date
    July 14, 1980
    Product Code
    DIW
    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
    DIW Hemagglutination Inhibition, Methadone

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    Other Clearances by Technam, Inc.

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