GKE · Osmotic Fragility Testing
Hematology · 21 CFR 864.6600 · Class 1
Overview
| Product Code | GKE |
|---|---|
| Device Name | Osmotic Fragility Testing |
| Regulation | 21 CFR 864.6600 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
An osmotic fragility test is a device used to determine the resistance of red blood cells to hemolysis (destruction) in varying concentrations of hypotonic saline solutions.
Classification Rationale
Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
