510(k) K124006 ยท PFR System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY
| Applicant | Illumina, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 19, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K124006
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.