510(k) K974027 ยท CDP Radioimmunoassay, Total Triiodothyronine
AURAFLEX FT3 150 TEST PACK, AURAFLEX FT3 CALIBRATOR PACK
| Applicant | Alfa Biotech (Uk) , Ltd., Aldershot, GB |
| Decision | Substantially Equivalent, Feb 2, 1998 |
| Received | Oct 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974027
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.