510(k) K974840 ยท DJG Enzyme Immunoassay, Opiates
ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Apr 24, 1998 |
| Received | Dec 24, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974840
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.