PCN · Class II · 21 CFR 866.5510

FDA Product Code PCN: Immunoglobulin G Kappa Heavy And Light Chain Combined

Intended For The In-vitro Quantification Of Igg Kappa Concentration In Human Serum.

Leading manufacturers include The Binding Site Group , Ltd..

3
Total
3
Cleared
129d
Avg days
2013
Since

FDA 510(k) Cleared Immunoglobulin G Kappa Heavy And Light Chain Combined Devices (Product Code PCN)

3 devices
1–3 of 3
Cleared Feb 15, 2018
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
K172613
The Binding Site Group , Ltd.
Immunology · 168d
Cleared Oct 04, 2016
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
K161854
The Binding Site Group , Ltd.
Immunology · 90d

About Product Code PCN - Regulatory Context