510(k) K130275 ยท DJG Enzyme Immunoassay, Opiates
QUIKSCREEN MULTI (MDMA AND OPI) OTC DRUG CUP TEST
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 26, 2013 |
| Received | Feb 4, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130275
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.