510(k) K014101 ยท DJG Enzyme Immunoassay, Opiates
RAPIDONE-OXY TEST
| Applicant | American Bio Medica Corp., Columbia MD, US |
| Decision | Substantially Equivalent, Mar 20, 2002 |
| Received | Dec 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K014101
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.