FDA product code GKE
Osmotic Fragility Testing
Hematology·Class 1·21 CFR 864.6600
US regulatory classifications
- US Product Code (FDA)
- GKEView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 864.6600View CFR Regulation →
- Medical specialty
- Hematology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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About this record
Osmotic Fragility Testing is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.