510(k) K132750 ยท PFS System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY
| Applicant | Illumina, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 19, 2013 |
| Received | Sep 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132750
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2014 | Illumina Inc Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Terminated |
PFS | None listed |
| Dec 23, 2014 | Illumina Inc Illumina MiSeqDx Universal Kit 1.0, PN 15039608
The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral Terminated |
PFS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.