JFR · Class II · 21 CFR 866.5210

FDA Product Code JFR: Indirect Copper Assay, Ceruloplasmin

Leading manufacturers include Sentinel Ch. Srl and Technicon Instruments Corp..

2
Total
2
Cleared
78d
Avg days
1988
Since

FDA 510(k) Cleared Indirect Copper Assay, Ceruloplasmin Devices (Product Code JFR)

2 devices
1–2 of 2
Cleared Oct 21, 2005
SENTINEL CERULOPLASMIN
K051456
Sentinel Ch. Srl
Immunology · 141d
Cleared Jul 08, 1988
CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
K882622
Technicon Instruments Corp.
Immunology · 14d

About Product Code JFR - Regulatory Context