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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 30, 2003 | K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY Bayer Corp. | NCW |
| Sep 29, 2000 | K994112 | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) Oncogene Science, Inc. | NCW |
| Sep 29, 2000 | K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY Bayer Corp. | NCW |
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