K861155 is an FDA 510(k) clearance for the EMIT DESIPRAMINE ASSAY. This device is classified as a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFG).
Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on May 2, 1986, 35 days after receiving the submission on March 28, 1986.
This device falls under the Toxicology 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 | K861155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 1986 |
| Decision Date | May 02, 1986 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| 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. |