Product code NFW
- Device name
- Test, Cannabinoid, Over The Counter
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3870
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252523 | Healgen® Accurate Oral Fluid Drug Test COT/THC; Healgen® Accurate Oral Fluid Drug Test | Healgen Scientific,, LLC | 2026-02-12 |
| K231978 | BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-08-31 |
| K192301 | BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip | Shenzhen Bioeasy Biotechnology Co., Ltd. | 2019-09-20 |
| K191924 | SAFECARE® THC Urine Strip Test | Safecare Biotech (Hangzhou) Co., Ltd. | 2019-08-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10722066015084 | Rapid Response | BTNX Inc | 2026-05-15 |
| 10722066015053 | Rapid Response | BTNX Inc | 2026-05-15 |
| 10648564316280 | SnapCheckDx Rapid Urine THC Test | Hangzhou Aichek Medical Technology Co., Ltd. | 2026-05-12 |
| 16936983131657 | Multi-Drug Test Cup (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 16936983131640 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 16936983131633 | Multi-Drug Rapid Test Panel (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2026-04-16 |
| 10722066011277 | Rapid Response | BTNX Inc | 2026-01-19 |
| 10722066011260 | Rapid Response | BTNX Inc | 2026-01-19 |
| 10722066009083 | Rapid Response | BTNX Inc | 2025-10-03 |
| 10722066010973 | Rapid Response | BTNX Inc | 2025-07-08 |
| 10722066009076 | Rapid Response | BTNX Inc | 2025-03-28 |
| 10722066008291 | Rapid Response | BTNX Inc | 2024-08-15 |
| 10722066009014 | Rapid Response | BTNX Inc | 2024-08-15 |
| 10722066008857 | Rapid Response | BTNX Inc | 2024-08-14 |
| 10722066008253 | Rapid Response | BTNX Inc | 2024-04-01 |
| 10722066008055 | Rapid Response | BTNX Inc | 2024-04-01 |
| 10722066008260 | Rapid Response | BTNX Inc | 2024-04-01 |
| 10722066007751 | Rapid Response | BTNX Inc | 2024-02-21 |
| 10722066007546 | Rapid Response | BTNX Inc | 2023-08-04 |
| 10722066007553 | Rapid Response | BTNX Inc | 2023-08-04 |
| 10722066007560 | Rapid Response | BTNX Inc | 2023-08-04 |
| 10722066005672 | Rapid Response | BTNX Inc | 2022-12-07 |
| 10840050502430 | Reveal | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 10722066005658 | Rapid Response | BTNX Inc | 2022-05-11 |
| 10722066005641 | Rapid Response | BTNX Inc | 2022-05-11 |
| 10722066005368 | Rapid Response | BTNX Inc | 2022-03-21 |
| 10817405021373 | UScreen® | Instant Technologies, Inc. | 2021-05-25 |
| 10817405021298 | T-Cup® Compact | Instant Technologies, Inc. | 2020-07-22 |
| 10763924084651 | Accutest | JANT PHARMACAL CORPORATION | 2016-09-24 |
| 10763924093639 | Accutest | JANT PHARMACAL CORPORATION | 2016-09-24 |