510(k) K944697 ยท CEC Radioimmunoassay, Free Thyroxine
AURA FLEX FT4 200 TEST PACK, FT4 CALIBRATOR PACK
| Applicant | Organon Teknika Corp., Durham NC, US |
| Decision | Substantially Equivalent, Feb 22, 1995 |
| Received | Sep 23, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944697
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.