PCNClass II
Immunoglobulin G Kappa Heavy And Light Chain Combined
Immunology · 21 CFR 866.5510
Intended for the in-vitro quantification of IgG kappa concentration in human serum.
MDR events0All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances3All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
6 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- The Binding Site Group , Ltd.Feb 15, 2018
K172613 · Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
- The Binding Site Group , Ltd.Oct 4, 2016
K161854 · Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
- The Binding SiteDec 20, 2013
K132555 · HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT