510(k) K911954 ยท DJR Enzyme Immunoassay, Methadone
REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION
| Applicant | Bio-Rad, Hercules CA, US |
| Decision | Substantially Equivalent, May 23, 1991 |
| Received | May 1, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911954
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.