510(k) K894522 ยท DLJ Calibrators, Drug Specific
FPR DIGOXIN CALIBRATOR KIT
| Applicant | Colony Laboratories, Inc., Washington DC, US |
| Decision | Substantially Equivalent, Sep 25, 1989 |
| Received | Jul 20, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894522
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.