Ucp Compact Drug Tests
FDA 510(k) K152908 · Ucp Biosciences, Inc.
510(k) numberK152908
Submission
- Device name
- Ucp Compact Drug Tests
- Applicant
- Ucp Biosciences, Inc.
San Jose, CA, US - Received
- October 1, 2015
- Decision date
- May 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | 04/20/2011SE |
| 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 Compact Drug Tests cleared by the FDA?
Ucp Compact Drug Tests (K152908) received a 510(k) decision of Substantially Equivalent on May 3, 2016, 215 days after the submission was received.
What is the product code of K152908?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.