510(k) K172913 ยท NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
cobas Factor II and Factor V Test
| Applicant | Roche Molecular Systems, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Jan 12, 2018 |
| Received | Sep 25, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172913
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.