NCW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- System, Test, Her-2/Neu, Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| BAYER ADVIA CENTAUR HER-2/NEU ASSAY (K024017) | Bayer Corp. | 2003-01-30 |
| MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) (K994112) | Oncogene Science, Inc. | 2000-09-29 |
| BAYER IMMUNO 1 HER-2/NEU ASSAY (K992228) | Bayer Corp. | 2000-09-29 |
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Every clearance here is in the API, with alerts when new ones post.