CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
FDA 510(k) K252118 · Hangzhou Clongene Biotech Co., Ltd.
510(k) numberK252118
Submission
- Device name
- CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup
- Applicant
- Hangzhou Clongene Biotech Co., Ltd.
Hangzhou, CN - Received
- July 7, 2025
- Decision date
- August 27, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NFT – Test, Amphetamine, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
Other 510(k)s with product code NFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261409 | BioTeke® Multi-Drug Urine Test CupNFT · Traditional | Bioteke Corporation (Wuxi) Co., Ltd. | 09/10/2026SE |
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 07/17/2026SE |
| K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test PanelNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 05/22/2026SE |
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 04/28/2026SE |
| K260355 | Webest Multi-Drug Urine Cup; Webest Home Multi-Drug Urine CupNFT · Traditional | WEBEST Biotech,, LLC | 03/09/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 11/18/2025SE |
| K252867 | VINScreen Urine Drug Test Cup; VINScreen Urine Drug Home Test CupNFT · Traditional | Advin Biotech, Inc. | 10/09/2025SE |
| K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test CupNFT · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 09/12/2025SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 08/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 04/04/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K253318 | Clungene RSV Antigen Rapid TestGQG · Traditional | 01/30/2026SE |
| K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test CassetteNGL · Traditional | 11/08/2024SE |
| K193132 | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip…LCX · Traditional | 12/11/2019SE |
| K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL · Traditional | 03/21/2019SE |
| K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL · Traditional | 07/26/2018SE |
| K180255 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupPTH · Traditional | 02/28/2018SE |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsDKZ · Traditional | 08/30/2016SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | 03/18/2016SE |
Questions and answers
When was CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup cleared by the FDA?
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup (K252118) received a 510(k) decision of Substantially Equivalent on August 27, 2025, 51 days after the submission was received.
What is the product code of K252118?
The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.