Wondfo Multi-Drug Urine Test Cup, Panel
FDA 510(k) K133968 · Guangzhou Wondfo Biotech Co., Ltd.
510(k) numberK133968
Submission
- Device name
- Wondfo Multi-Drug Urine Test Cup, Panel
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Gaithersburg, MD, US - Received
- December 26, 2013
- Decision date
- February 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | 04/28/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | 11/18/2025SE |
| K251289 | WELLlife COVID-19 Antigen Test RxQVF · Dual Track | 10/22/2025SE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional | 09/30/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | 07/16/2024SE |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT · Traditional | 09/25/2020SE |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test CupNFT · Traditional | 12/03/2018SE |
| K173229 | Preview Digital Pregnancy TestLCX · Traditional | 03/12/2018SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | 05/14/2017SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | 06/27/2016SE |
Questions and answers
When was Wondfo Multi-Drug Urine Test Cup, Panel cleared by the FDA?
Wondfo Multi-Drug Urine Test Cup, Panel (K133968) received a 510(k) decision of Substantially Equivalent on February 25, 2014, 61 days after the submission was received.
What is the product code of K133968?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.