510(k) K051054 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
VISULIZE FACTOR IX ANTIGEN KIT
| Applicant | Affinity Biologicals, Inc., Ancaster, Ontario, CA |
| Decision | Substantially Equivalent, Jun 29, 2005 |
| Received | Apr 26, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051054
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.