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

    UCP DRUG SCREENING TEST CUPS

    K Number: K110515 · Decision Apr 20, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    88
    Registration Numbers
    88
    Same Product Code
    99
    Applicant Total
    14
    Review Days
    56

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    UCP DRUG SCREENING TEST CUPS
    K Number
    K110515
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    862.3150
    Medical Specialty
    Clinical Toxicology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ucp Biosciences, Inc.
    Date Received
    February 23, 2011
    Decision Date
    April 20, 2011
    Product Code
    DIS
    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
    DIS Enzyme Immunoassay, Barbiturate

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (DIS), ordered by most recent decision date.

    Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    CR3 Keyless Split Sample Cup Secobarbital- Methadone

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    GenPrime Snap-Top Split Key Cup

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology
    View all

    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
    K091612 UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;
    K091588 UCP HOME DRUG SCREENING TESTS
    Search all 14 clearances from Ucp Biosciences, Inc. →