SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
FDA 510(k) K201120 · Safecare Biotech (Hangzhou) Co., Ltd.
510(k) numberK201120
Submission
- Device name
- SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card
- Applicant
- Safecare Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- April 27, 2020
- Decision date
- May 27, 2020
- 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 |
More from Assure Tech., LLC
| 510(k) | Device | Decision |
|---|---|---|
| K242767 | Safecare Urinary Tract Infection TestJMT · Traditional | 01/10/2025SE |
| K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test CassetteNGL · Traditional | 04/10/2024SE |
| K202453 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 03/24/2021SE |
| K200133 | hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test MidstreamLCX · Traditional | 08/13/2020SE |
| K191924 | SAFECARE® THC Urine Strip TestNFW · Traditional | 08/16/2019SE |
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip CardNGG · Traditional | 11/19/2018SE |
| K181968 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-CardNFT · Traditional | 08/20/2018SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | 03/18/2016SE |
Questions and answers
When was SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card cleared by the FDA?
SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card (K201120) received a 510(k) decision of Substantially Equivalent on May 27, 2020, 30 days after the submission was received.
What is the product code of K201120?
The FDA product code is NFT – Test, Amphetamine, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.3100.