K180255 is an FDA 510(k) clearance for the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup. This device is classified as a Test, Barbiturate, Over The Counter (Class II - Special Controls, product code PTH).
Submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on February 28, 2018, 29 days after receiving the submission on January 30, 2018.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3150. The Barbiturate Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Barbiturates In Human Urine..
| 510(k) Number | K180255 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2018 |
| Decision Date | February 28, 2018 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | PTH - Test, Barbiturate, Over The Counter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3150 |
| Definition | The Barbiturate Test Is An In Vitro Diagnostic Test For The Qualitative Analysis Of Barbiturates In Human Urine. |