510(k) K974505 ยท DBF Ferritin, Antigen, Antiserum, Control
AURAFLEX FERRITIN 200 TEST PACK 80500, AURAFLEX FERRITIN CALIBRATOR PACK 80501
| Applicant | Alfa Biotech (Uk) , Ltd., Aldershot Hants, GB |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Dec 1, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974505
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.