510(k) K013318 ยท KFF Assay, Heparin
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
| Applicant | American Diagnostica, Inc., Greenwich CT, US |
| Decision | Substantially Equivalent, Mar 8, 2002 |
| Received | Oct 5, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013318
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.