510(k) K013305 ยท KFF Assay, Heparin
ENOXAPARIN TEST CARD
| Applicant | Cardiovascular Diagnostics, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Aug 23, 2002 |
| Received | Oct 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013305
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.