K844951 is an FDA 510(k) clearance for the EMIT IMIPRAMINE 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 June 28, 1985, 190 days after receiving the submission on December 20, 1984.
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 | K844951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1984 |
| Decision Date | June 28, 1985 |
| Days to Decision | 190 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. |