Submission Details
| 510(k) Number | K153050 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2015 |
| Decision Date | April 26, 2016 |
| Days to Decision | 189 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Special
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
Apr 2016
Decision
189d
Days
Class 2
Risk
About This 510(k) Submission
K153050 is an FDA 510(k) clearance for the Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on April 26, 2016, 189 days after receiving the submission on October 20, 2015. 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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