510(k) K091284 ยท GGN Plasma, Coagulation Control
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
| Applicant | Affinity Biologicals, Inc., Ancaster, Ontario, CA |
| Decision | Substantially Equivalent, Oct 28, 2009 |
| Received | May 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091284
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.