Definition: Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.
| Device Type ID | 6218 |
| Device Name | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Physical State | The Device May Be Composed Of A Collection Apparatus And / Or Measurement Assay. |
| Technical Method | Serum Or Urine Are Collected And Analyzed For The Presence Of Antidepressant Drugs. |
| Target Area | Serum Or Urine. |
| 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) |
| CFR Regulation Number | 862.3910 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LFG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6218 |
| Device | Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Product Code | LFG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Tricyclic Antidepressant Drugs Test System. |
| CFR Regulation Number | 862.3910 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GUANGZHOU WONDFO BIOTECH CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HEALGEN SCIENTIFIC LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 1 |