Panels › Immunology › Product code NCW · Class 2
System, Test, Her-2/Neu, Monitoring
Regulation 866.6010
0510(k)s in 12 months (3 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in NCW
| Company | 510(k)s | Recalls |
|---|---|---|
| Bayer Corp. | 2 | 0 |
| Oncogene Science, Inc. | 1 | 0 |
| Siemens Healthcare Diagnostics, Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2020 | Siemens Healthcare Diagnostics, Inc Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes:
(01)00630414599151(10)98034139(17)20210130 and (01)00630414599151(10)32478139(17)20210130
Atellica IM HER-2/neu (H Terminated |
NCW | K024017 |
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