AssureTech Panel Dip Test, AssureTech Quick Cup Test
FDA 510(k) K170049 · Assure Tech. (Hangzhou) Co, Ltd.
510(k) numberK170049
Submission
- Device name
- AssureTech Panel Dip Test, AssureTech Quick Cup Test
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
Hangzhou, CN - Received
- January 5, 2017
- Decision date
- May 2, 2017
- 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 |
| K252118 | CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy CupNFT · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 08/27/2025SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | Assure Tech., LLC | 08/15/2025SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K233174 | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test MidstreamLCX · Traditional | 02/05/2024SE |
| K201630 | AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup TestsDJG · Traditional | 08/12/2021SE |
| K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT · Traditional | 08/20/2018SE |
| K180349 | AssureTech Panel Dip Tests, AssureTech Quick Cup TestsNFT · Traditional | 04/05/2018SE |
| K161044 | AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJC · Traditional | 07/06/2016SE |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)…DKZ · Traditional | 03/31/2016SE |
Questions and answers
When was AssureTech Panel Dip Test, AssureTech Quick Cup Test cleared by the FDA?
AssureTech Panel Dip Test, AssureTech Quick Cup Test (K170049) received a 510(k) decision of Substantially Equivalent on May 2, 2017, 117 days after the submission was received.
What is the product code of K170049?
The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.