510(k) K122064 ยท DJG Enzyme Immunoassay, Opiates
FORSURE ONE STEP BUPRENORPHINE CUP TEST DEVICE
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, May 7, 2013 |
| Received | Jul 13, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122064
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.