510(k) K131110 ยท DKZ Enzyme Immunoassay, Amphetamine
ONE STEP SINGLE/MULTI-DRUG TEST CUP; ONE STEP SINGLE SINGLE/MULTI-DRUG TEST DIPCARD
| Applicant | Co-Innovation Biotech Co., Ltd., Guangzhou, Guangdong, CN |
| Decision | Substantially Equivalent, Jan 15, 2014 |
| Received | Apr 19, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131110
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.