510(k) K950369 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
VISUALINE II COCAINE
| Applicant | Sun Biomedical Laboratories, Inc., Cherry Hill NJ, US |
| Decision | Substantially Equivalent, Mar 21, 1995 |
| Received | Jan 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950369
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.