PDE — Immunoglobulin M Kappa Heavy And Light Chain Combined Class II
FDA product code PDE covers "Immunoglobulin M Kappa Heavy And Light Chain Combined", a Class II medical device regulated under 21 CFR 866.5510. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PDE
- Device Class
- Class II
- Regulation Number
- 866.5510
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
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.