Device Type ID | 6242 |
Device Name | Test, Morphine, Over The Counter |
Regulation Description | Morphine 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 | 862.3640 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | NGI |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 6242 |
Device | Test, Morphine, Over The Counter |
Product Code | NGI |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Morphine Test System. |
CFR Regulation Number | 862.3640 [🔎] |