OPX · Class II · 21 CFR 866.5510

FDA Product Code OPX: Immunoglobulin A Kappa Heavy & Light Chain Combined

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

3
Total
3
Cleared
92d
Avg days
2014
Since

FDA 510(k) Cleared Immunoglobulin A Kappa Heavy & Light Chain Combined Devices (Product Code OPX)

3 devices
1–3 of 3
No devices found for this product code.

About Product Code OPX - Regulatory Context