510(k) K090844 ยท DJG Enzyme Immunoassay, Opiates
BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Jul 30, 2009 |
| Received | Mar 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090844
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.