Panels › Immunology › Product code NUA · Class 2
System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection
Regulation 866.5900
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in NUA
| Company | 510(k)s | Recalls |
|---|---|---|
| Luminex Molecular Diagnostics, Inc. | 4 | 0 |
| Clinical Micro Sensors | 2 | 0 |
| Hologic, Inc | 0 | 2 |
| Tm Bioscience Corporation | 2 | 0 |
| Celera Diagnostics | 1 | 0 |
| Nanosphere, Inc. | 1 | 0 |
| Osmetech Molecular Diagnostics | 1 | 0 |
| Third Wave Technologies, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2016 | Hologic, Inc Hologic InPlex CF Molecular Test (IVD); Catalog Number: 95-432. Terminated |
NUA | K063787 |
| Mar 31, 2016 | Hologic, Inc CF InPlex ASR Card; Catalog Number: 95-0501. Terminated |
NUA | None listed |
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