| Device Type ID | 6237 |
| Device Name | Test, Amphetamine, Over The Counter |
| Regulation Description | Amphetamine Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NFT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 6237 |
| Device | Test, Amphetamine, Over The Counter |
| Product Code | NFT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Amphetamine Test System. |
| CFR Regulation Number | 862.3100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HANMEDICS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |