K143535 is an FDA 510(k) clearance for the CR3 Keyless Split Sample Cup Secobarbital- Methadone. This device is classified as a Enzyme Immunoassay, Barbiturate (Class II - Special Controls, product code DIS).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on January 13, 2015, 29 days after receiving the submission on December 15, 2014.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.3150.
| 510(k) Number | K143535 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2014 |
| Decision Date | January 13, 2015 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |