Panels › Immunology › Product code MMW · Class 2
System, Test, Tumor Marker, Monitoring, Bladder
Regulation 866.6010
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in MMW
| Company | 510(k)s | Recalls |
|---|---|---|
| Vysis | 3 | 1 |
| Bard Diagnostic Sciences,Inc. | 3 | 0 |
| Matritech, Inc. | 1 | 0 |
| Nucleix , Ltd. | 1 | 0 |
| Perimmune, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Vysis ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphobla Terminated |
MMW | K011031 K013785 |
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