NCW — System, Test, Her-2/Neu, Monitoring Class II
FDA Device Classification
Classification Details
- Product Code
- NCW
- Device Class
- Class II
- Regulation Number
- 866.6010
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K024017 | bayer | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | January 30, 2003 |
| K994112 | oncogene science | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | September 29, 2000 |
| K992228 | bayer | BAYER IMMUNO 1 HER-2/NEU ASSAY | September 29, 2000 |