K140748 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD. This device is classified as a Enzyme Immunoassay, Opiates (Class II - Special Controls, product code DJG).
Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on August 20, 2014, 148 days after receiving the submission on March 25, 2014.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3650.
| 510(k) Number | K140748 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 2014 |
| Decision Date | August 20, 2014 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DJG - Enzyme Immunoassay, Opiates |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3650 |