510(k) K050945 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ORAL FLUID COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAYS, CALIBRATORS & CONTROLS
| Applicant | Lin-Zhi International, Inc., Synnyvale CA, US |
| Decision | Substantially Equivalent, Mar 29, 2006 |
| Received | Apr 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050945
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.