510(k) K050321 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
ONTRAK TESTCARD 9
| Applicant | Varian, Inc., Lake Forest CA, US |
| Decision | Substantially Equivalent, Apr 18, 2005 |
| Received | Feb 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050321
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.