510(k) K113139 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
LZI COCAINE METABOLITE HOMOGENEOUS ENZYME IMMUNOASSAY,CALIBRATORS,CONTROLS
| Applicant | Lin-Zhi International, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 22, 2011 |
| Received | Oct 24, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113139
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.