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

    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION

    K Number: K935564 · Decision Jul 14, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    6
    Review Days
    603

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    Basic Information

    Device Name
    SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPIATES IN PERSPIRATION
    K Number
    K935564
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sudormed, Inc.
    Date Received
    November 18, 1993
    Decision Date
    July 14, 1995
    Product Code
    JKA
    Advisory Committee
    Clinical Chemistry
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Sudormed, Inc.

    K Number Device Name
    K936135 SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION
    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
    K902442 SUDORMED SWEAT PATCH SPECIMEN CONTAINER