GKE — Osmotic Fragility Testing Class I
FDA product code GKE covers "Osmotic Fragility Testing", a Class I medical device regulated under 21 CFR 864.6600. Submissions are reviewed by the Hematology panel.
Classification Details
- Product Code
- GKE
- Device Class
- Class I
- Regulation Number
- 864.6600
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No