510(k) K053422 ยท DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
RAPIDONE-COCAINE-150 TEST
| Applicant | American Bio Medica Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Jun 15, 2006 |
| Received | Dec 8, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053422
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.