System, Test, Her-2/Neu, Monitoring
The System, Test, Her-2/Neu, Monitoring (product code NCW) is an in vitro diagnostic system used to measure HER-2/neu protein or gene expression levels in patient specimens, typically to guide breast cancer therapy decisions. It is classified as an FDA Class 2 device within the Immunology specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
Basic Information
- Product Code
- NCW
- Device Class
- FDA class 2
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K024017 | BAYER ADVIA CENTAUR HER-2/NEU ASSAY | Jan 30, 2003 | Substantially Equivalent | BAYER CORP. |
| K994112 | MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA) | Sep 29, 2000 | Substantially Equivalent | ONCOGENE SCIENCE, INC. |
| K992228 | BAYER IMMUNO 1 HER-2/NEU ASSAY | Sep 29, 2000 | Substantially Equivalent | BAYER CORP. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.