Submission Details
| 510(k) Number | K180255 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
K180255 - CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
(FDA 510(k) Clearance)
Feb 2018
Decision
29d
Days
Class 2
Risk
K180255 is an FDA 510(k) clearance for the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, 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 review panel. Regulated under 21 CFR 862.3150.
Device Classification
| 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. |