K140215 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on June 16, 2014, 139 days after receiving the submission on January 28, 2014.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K140215 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 2014 |
| Decision Date | June 16, 2014 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | DIS - Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |