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 |
|---|---|---|---|
| 00840050500323 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500460 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500453 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500446 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500439 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500422 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500415 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500408 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500392 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500385 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500378 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500361 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500354 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500347 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500330 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500170 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500316 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500309 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500293 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500286 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500279 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500262 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500255 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500248 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500231 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500224 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500217 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500200 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500194 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |
| 00840050500187 | OneScreen | AMERICAN SCREENING, L.L.C. | 2022-11-11 |