510(k) K153050 ยท DJG Enzyme Immunoassay, Opiates
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Apr 26, 2016 |
| Received | Oct 20, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153050
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.