510(k) K042919 ยท GIS Test, Fibrinogen
FIBROTEK FIB
| Applicant | R2 Diagnostics, Inc., South Bend IN, US |
| Decision | Substantially Equivalent, Nov 29, 2004 |
| Received | Oct 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042919
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.