510(k) DEN030005 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
FACTOR V LEIDEN KIT
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Unknown, Dec 17, 2003 |
| Received | Dec 8, 2003 |
| Type | Post-NSE |
| FDA record | Open on fda.gov |
Recalls that name DEN030005
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.