NCW · Class II · 21 CFR 866.6010

FDA Product Code NCW: System, Test, Her-2/neu, Monitoring

Leading manufacturers include Bayer Corp..

3
Total
3
Cleared
270d
Avg days
2000
Since

FDA 510(k) Cleared System, Test, Her-2/neu, Monitoring Devices (Product Code NCW)

3 devices
1–3 of 3
Cleared Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017
Bayer Corp.
Immunology · 57d
Cleared Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228
Bayer Corp.
Immunology · 455d

About Product Code NCW - Regulatory Context