510(k) K093974 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING
| Applicant | Osmetech Molecular Diagnostics, Pasadena CA, US |
| Decision | Substantially Equivalent, Apr 22, 2010 |
| Received | Dec 23, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093974
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.