K150602 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Morphine - Methamphetamine. This device is classified as a Thin Layer Chromatography, Morphine (Class II - Special Controls, product code DNK).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 7, 2015, 28 days after receiving the submission on March 10, 2015.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3640.
| 510(k) Number | K150602 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2015 |
| Decision Date | April 07, 2015 |
| Days to Decision | 28 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 |