Device Type ID | 6241 |
Device Name | Test, Methamphetamine, Over The Counter |
Regulation Description | Methamphetamine 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 | 862.3610 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NGG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 6241 |
Device | Test, Methamphetamine, Over The Counter |
Product Code | NGG |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Methamphetamine Test System. |
CFR Regulation Number | 862.3610 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Ameditech Inc | III | Oct-25-2018 |