PKM — Chemiluminescent Immunoassay System Class N
FDA product code PKM covers "Chemiluminescent Immunoassay System", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- PKM
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Unknown
- Implant
- No
Definition
For in vitro diagnostic use in the quantitative measurement of hyaluronic acid in human serum.