PDE · Class II · 21 CFR 866.5510

FDA Product Code PDE: Immunoglobulin M Kappa Heavy And Light Chain Combined

Intended For The In-vitro Quantification Of Igm Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Igm Waldenstoms Macrolobulinaemia, In Conjunction With Other Clinical And Laboratory Findings.

Leading manufacturers include The Binding Site Group , Ltd..

2
Total
2
Cleared
128d
Avg days
2014
Since

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

2 devices
1–2 of 2
Cleared Dec 18, 2015
Optilite Hevylite IgM Kappa Kit
K152389
The Binding Site Group , Ltd.
Immunology · 116d
Cleared Aug 06, 2014
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
K140686
The Binding Site Group , Ltd.
Immunology · 140d

About Product Code PDE - Regulatory Context