510(k) K082118 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
XPERT HEMOSIL FACTOR II & FACTOR V ASSAY
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 18, 2009 |
| Received | Jul 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082118
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.