Product code NGG
- Device name
- Test, Methamphetamine, Over The Counter
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3610
- 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 |
|---|---|---|---|
| K182654 | SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card | Safecare Biotech (Hangzhou) Co., Ltd. | 2018-11-19 |
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 |