Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups
FDA 510(k) K123863 · Ucp Biosciences, Inc.
510(k) numberK123863
Submission
- Device name
- Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups
- Applicant
- Ucp Biosciences, Inc.
San Jose, CA, US - Received
- December 14, 2012
- Decision date
- January 9, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code DKZ
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| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 12/13/2023SE |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDKZ · Traditional | Xenta Biomedical Science Co., Ltd. | 05/19/2023SE |
| K200363 | Quidel Triage® TOX Drug Screen, 94600DKZ · Special | Quidel Cardiovascular, Inc. | 03/11/2020SE |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelDKZ · Traditional | Atlas Medical | 10/03/2019SE |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ · Traditional | Quidel Cardiovascular, Inc. | 06/19/2019SE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 03/27/2019SE |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…DKZ · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/14/2018SE |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | Phamatech, Inc. | 10/18/2018SE |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | Alfa Scientific Designs, Inc. | 02/23/2018SE |
More from Alfa Scientific Designs, Inc.
| 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 |
| 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 Test Cards, Ucp Compact Drug Test Cups cleared by the FDA?
Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups (K123863) received a 510(k) decision of Substantially Equivalent on January 9, 2013, 26 days after the submission was received.
What is the product code of K123863?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.