510(k) K012755 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
AUTODIMER ASSAY MODEL # 1431
| Applicant | Xtrana, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Mar 15, 2002 |
| Received | Aug 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012755
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.