CHN · Class II · 21 CFR 866.5210

FDA Product Code CHN: Immunochemical, Ceruloplasmin

Leading manufacturers include Roche Diagnostics Corp., Dade Behring, Inc. and Roche Diagnostics.

3
Total
3
Cleared
178d
Avg days
2007
Since

FDA 510(k) Cleared Immunochemical, Ceruloplasmin Devices (Product Code CHN)

3 devices
1–3 of 3
Cleared Mar 18, 2010
TINA-QUANT CERULOPLASMIN
K091741
Roche Diagnostics
Immunology · 275d
Cleared Feb 15, 2007
DIMENSION VISTA
K063655
Dade Behring, Inc.
Immunology · 69d
Cleared Jan 31, 2007
CERULOPLASMIN, MODEL 2055953
K062114
Roche Diagnostics Corp.
Immunology · 191d

About Product Code CHN - Regulatory Context