Submission Details
| 510(k) Number | K140215 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 28, 2014 |
| Decision Date | June 16, 2014 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD
Jun 2014
Decision
139d
Days
Class 2
Risk
About This 510(k) Submission
K140215 is an FDA 510(k) clearance for the ONE STEP SINGLE/MULTI-DRUG TEST CUP/DIPCARD, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Co-Innovation Biotech Co., Ltd. (Guangzhou, Guangdong, CN). The FDA issued a Cleared decision on June 16, 2014, 139 days after receiving the submission on January 28, 2014. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.
Device Classification
| Product Code | DIS — Enzyme Immunoassay, Barbiturate |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3150 |
Manufacturer
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