510(k) K013545 ยท DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Nov 15, 2001 |
| Received | Oct 24, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013545
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.