Product code NCW— Immunology
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
- Classification name
- System, Test, Her-2/Neu, Monitoring
- Device class
- Class 2
- Regulation
- 21 CFR 866.6010
- Advisory panel
- Immunology
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code NCW
FDA has cleared devices under product code NCW between 2000 and 2003, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2003
- 2000
Top applicants under product code NCW
Recent clearances under product code NCW
Data sourced from openFDA. This site is unofficial and independent of the FDA.