KSM — System, Test, Combs, Automated Class II
FDA product code KSM covers "System, Test, Combs, Automated", a Class II medical device regulated under 21 CFR 864.9300. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- KSM
- Device Class
- Class II
- Regulation Number
- 864.9300
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No