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

    UCP MULTIPLE DRUG SCREEN TEST CUPS

    K Number: K072062 · Decision Sep 20, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    20
    Applicant Total
    14
    Review Days
    55

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    Basic Information

    Device Name
    UCP MULTIPLE DRUG SCREEN TEST CUPS
    K Number
    K072062
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3910
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ucp Biosciences, Inc.
    Date Received
    July 27, 2007
    Decision Date
    September 20, 2007
    Product Code
    LFG
    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
    LFG Radioimmunoassay, Tricyclic Antidepressant Drugs

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    Other Clearances by Ucp Biosciences, Inc.

    K Number Device Name
    K152908 UCP COMPACT DRUG TESTS
    K151213 UCP Drug Test Mini Cups
    K132812 UCP MULTI-DRUG TEST KEY CUPS
    K131236 UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP
    K131811 UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    K130463 UCP HOME DRUG SCREENING TEST; CARDS, CUPS
    K123863 UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
    K122419 UCP HOME DRUG SCREENING TEST CUPS
    K110515 UCP DRUG SCREENING TEST CUPS
    K091612 UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;
    Search all 14 clearances from Ucp Biosciences, Inc. →