PCN

Immunoglobulin G Kappa Heavy And Light Chain Combined

Product code

PCN

Device name

Immunoglobulin G Kappa Heavy And Light Chain Combined

Device class

Class 2

21 CFR

21 CFR 866.5510

Medical specialty

Immunology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

Intended for the in-vitro quantification of IgG kappa concentration in human serum.

Definition text from the FDA device classification database (U.S. federal government work, public domain).