510(k) K972835 ยท DLJ Calibrators, Drug Specific
50NG/ML COCAINE METABOLITE CALIBRATOR
| Applicant | Diagnostic Reagents, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 28, 1997 |
| Received | Jul 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972835
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.