510(k) K100943 ยท NPR Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
INVADER FACTOR II
| Applicant | Hologic, Inc., Malborough MA, US |
| Decision | Substantially Equivalent, Jun 2, 2011 |
| Received | Apr 6, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100943
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.