510(k) K830462 ยท DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
ABUSCREEN RADIOUMMUNOASSAY--URINE
| Applicant | Hoffmann-La Roche, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Mar 24, 1983 |
| Received | Feb 15, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830462
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.