Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt
Device Code: 6272
Product Code(s):
PVK Definition: The Tricyclic Antidepressant Drugs Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Tricyclic Antidepressant Drugs For Employment And Insurance Testing. FDA Has Exempted These Devices From The Premarket Notification Requirement By
Device Classification Information
| Device Type ID | 6272 |
| Device Name | Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt |
| Physical State | In Vitro Diagnostic Device |
| Technical Method | Immunoassay |
| Target Area | In Vitro Specimen |
| Regulation Description | Tricyclic Antidepressant Drugs Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.3910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PVK |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6272 |
| Device | Test, Tricyclic Antidepressant Drugs, Employment And Insurance Testing, Exempt |
| Product Code | PVK |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tricyclic Antidepressant Drugs Test System. |
| CFR Regulation Number | 862.3910 [🔎] |
TPLC Last Update: 2019-04-02 21:19:41