Submission Details
| 510(k) Number | K240698 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2024 |
| Decision Date | May 10, 2024 |
| Days to Decision | 57 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
Dochek? Multi-Drug Urine Test Dipcard Rx; Dochek? Multi-Drug Urine Test Dipcard
May 2024
Decision
57d
Days
Class 2
Risk
About This 510(k) Submission
K240698 is an FDA 510(k) clearance for the Dochek? Multi-Drug Urine Test Dipcard Rx; Dochek? Multi-Drug Urine Test Dipcard, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Guangzhou Decheng Biotechnology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on May 10, 2024, 57 days after receiving the submission on March 14, 2024. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.
Device Classification
| Product Code | DJG — Enzyme Immunoassay, Opiates |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3650 |
Manufacturer
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