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

    CAPITOL URINE DRUG SCREEN COLLECTION KIT

    K Number: K951122 · Decision May 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    67

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    Basic Information

    Device Name
    CAPITOL URINE DRUG SCREEN COLLECTION KIT
    K Number
    K951122
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3250
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Harry A. Schlakman
    Date Received
    February 27, 1995
    Decision Date
    May 5, 1995
    Product Code
    KDW
    Advisory Committee
    Pathology
    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
    KDW Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

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    Other Clearances by Harry A. Schlakman

    K Number Device Name
    K945480 MOSS(R) STEEL BREAKAWAY(R) INTRODUCER