510(k) K935055 ยท DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)
| Applicant | Roche Diagnostic Systems, Inc., Branchburg NJ, US |
| Decision | Substantially Equivalent, Aug 9, 1994 |
| Received | Oct 20, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935055
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.