Ucp Drug Screening Test Cups
FDA 510(k) K110515 · Ucp Biosciences, Inc.
510(k) numberK110515
Submission
- Device name
- Ucp Drug Screening Test Cups
- Applicant
- Ucp Biosciences, Inc.
San Jose, CA, US - Received
- February 23, 2011
- Decision date
- April 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat…DIS · Traditional | Ortho-Clinical Diagnostics | 01/05/2007SE |
More from Ortho-Clinical Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K152908 | Ucp Compact Drug TestsDKZ · Traditional | 05/03/2016SE |
| K151213 | UCP Drug Test Mini CupsDKZ · Special | 08/21/2015SE |
| K132812 | Ucp Multi-Drug Test Key CupsDKZ · Traditional | 03/06/2014SE |
| K131236 | Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream…LCX · Traditional | 11/07/2013SE |
| K131811 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | 07/19/2013SE |
| K130463 | Ucp Home Drug Screening Test; Cards, CupsDKZ · Traditional | 05/15/2013SE |
| K123863 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | 01/09/2013SE |
| K122419 | Ucp Home Drug Screening Test CupsDKZ · Traditional | 11/30/2012SE |
| K091612 | Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;DJG · Traditional | 02/24/2010SE |
| K091588 | Ucp Home Drug Screening TestsDKZ · Traditional | 09/04/2009SE |
Questions and answers
When was Ucp Drug Screening Test Cups cleared by the FDA?
Ucp Drug Screening Test Cups (K110515) received a 510(k) decision of Substantially Equivalent on April 20, 2011, 56 days after the submission was received.
What is the product code of K110515?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.