510(k) K951319 ยท DOE Radioimmunoassay, Morphine (125-I), Goat Antibody Ammonium Sulfate Sep.
ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION
| Applicant | Roche Diagnostic Systems, Inc., Somerville NJ, US |
| Decision | Substantially Equivalent, Jun 1, 1995 |
| Received | Mar 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951319
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.