GHK · Centrifuge, Microsedimentation
Hematology · 21 CFR 864.5350 · Class 1
Overview
| Product Code | GHK |
|---|---|
| Device Name | Centrifuge, Microsedimentation |
| Regulation | 21 CFR 864.5350 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.
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.
