510(k) K972384 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
AQ ONE STEP COCAINE TEST
| Applicant | Bionike Laboratories, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Aug 6, 1997 |
| Received | Jun 26, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972384
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.