510(k) K042990 ยท DJG Enzyme Immunoassay, Opiates
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
| Applicant | Tianjin New Bay Bioresearch Co., Ltd., Carlsbad CA, US |
| Decision | Substantially Equivalent, May 10, 2005 |
| Received | Oct 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042990
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.