K022693 is an FDA 510(k) clearance for the INSTANT-VIEW TCA URINE TEST. This device is classified as a Thin Layer Chromatography, Tricyclic Antidepressant Drugs (Class II - Special Controls, product code MLK).
Submitted by Alfa Scientific Designs, Inc. (Poway, US). The FDA issued a Cleared decision on December 9, 2002, 118 days after receiving the submission on August 13, 2002.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3910.
| 510(k) Number | K022693 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2002 |
| Decision Date | December 09, 2002 |
| Days to Decision | 118 days |
| Submission Type | Abbreviated |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | MLK — Thin Layer Chromatography, Tricyclic Antidepressant Drugs |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3910 |