DeviceClearance

Product code PCN— Immunology

HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT

Classification name
Immunoglobulin G Kappa Heavy And Light Chain Combined
Device class
Class 2
Regulation
21 CFR 866.5510
Advisory panel
Immunology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code PCN under 21 CFR 866.5510, via openFDA

Market context for product code PCN

FDA has cleared 3 devices under product code PCN between 2013 and 2018, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PCN

Recent clearances under product code PCN

Data sourced from openFDA. This site is unofficial and independent of the FDA.