K021526 is an FDA 510(k) clearance for the ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE. This device is classified as a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code LFG).
Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on July 17, 2002, 68 days after receiving the submission on May 10, 2002.
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 | K021526 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2002 |
| Decision Date | July 17, 2002 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| 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. |