510(k) K042687 ยท MIF Prothrombin Fragment 1.2
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
| Applicant | Dade Behring, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 10, 2004 |
| Received | Sep 29, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042687
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.