K821652 is an FDA 510(k) clearance for the DOXEPIN TRI-CY TEST SET. This device is classified as a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFG).
Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 14, 1982, 11 days after receiving the submission on June 3, 1982.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3910. Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine..
| 510(k) Number | K821652 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 03, 1982 |
| Decision Date | June 14, 1982 |
| Days to Decision | 11 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3910 |
| Definition | Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine. |