510(k) K042760 ยท GGN Plasma, Coagulation Control
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
| Applicant | Pentapharm , Ltd., Washington DC, US |
| Decision | Substantially Equivalent, Dec 22, 2004 |
| Received | Oct 5, 2004 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K042760
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.