Panels › Immunology › Product code PFS · Class 2
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Regulation 866.5900
0510(k)s in 12 months (1 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Illumina, Inc. | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2013 | K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY Illumina, Inc. | PFS |
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