K151557 is an FDA 510(k) clearance for the EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine. This device is classified as a Thin Layer Chromatography, Morphine (Class II - Special Controls, product code DNK).
Submitted by Nantong Egens Biotech Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on July 16, 2015, 36 days after receiving the submission on June 10, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K151557 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2015 |
| Decision Date | July 16, 2015 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DNK — Thin Layer Chromatography, Morphine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3640 |