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.

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
No devices found for this product code.

About Product Code PDE - Regulatory Context