510(k) K971141 ยท CEC Radioimmunoassay, Free Thyroxine
FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM
| Applicant | Dade Chemistry Systems, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Apr 28, 1997 |
| Received | Mar 28, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971141
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.