510(k) K020763 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
COCAINE METABOLITE ENZYME IMMUNOASSAY MODELS #0030 (500 TESTS KIT), #0031 (5000 TESTS KIT)
| Applicant | Lin-Zhi International, Inc., San Jose CA, US |
| Decision | Substantially Equivalent, May 10, 2002 |
| Received | Mar 7, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020763
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.