K970579 is an FDA 510(k) clearance for the ONE STEP MORPHINE CARD TEST. This device is classified as a Thin Layer Chromatography, Morphine (Class II - Special Controls, product code DNK).
Submitted by Teco Diagnostics (Anaheim, US). The FDA issued a Cleared decision on July 3, 1997, 139 days after receiving the submission on February 14, 1997.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K970579 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 1997 |
| Decision Date | July 03, 1997 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Statement |
| Product Code | DNK — Thin Layer Chromatography, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |