Submission Details
| 510(k) Number | K140748 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 25, 2014 |
| Decision Date | August 20, 2014 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD
Aug 2014
Decision
148d
Days
Class 2
Risk
About This 510(k) Submission
K140748 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP, ONE STEP SINGLE/MULTI-DRUG TEST DIPCARD, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on August 20, 2014, 148 days after receiving the submission on March 25, 2014. 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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