510(k) K864168 ยท DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
MORPHINE ROCHE (R) EIA TEST
| Applicant | Roche Diagnostic Systems, Inc., Nutley NJ, US |
| Decision | Substantially Equivalent, Mar 16, 1987 |
| Received | Oct 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864168
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.