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

    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION

    K Number: K936135 · Decision Jun 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    15
    Applicant Total
    6
    Review Days
    895

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    Basic Information

    Device Name
    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
    K Number
    K936135
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.3870
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sudormed, Inc.
    Date Received
    December 28, 1993
    Decision Date
    June 10, 1996
    Product Code
    LAT
    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
    LAT Radioimmunoassay, Cannabinoid(S)

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    Other Clearances by Sudormed, Inc.

    K Number Device Name
    K936240 SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)
    K935588 SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMPHETAMINES IN PERSPIRATION
    K926253 SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINE
    K935564 SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION
    K902442 SUDORMED SWEAT PATCH SPECIMEN CONTAINER