Submission Details
| 510(k) Number | K190412 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 21, 2019 |
| Decision Date | March 21, 2019 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Mar 2019
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K190412 is an FDA 510(k) clearance for the CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup, a Test, Opiates, Over The Counter (Class II — Special Controls, product code NGL), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 21, 2019, 28 days after receiving the submission on February 21, 2019. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | NGL — Test, Opiates, Over The Counter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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