21 CFR 864.5350 — Centrifuge, Microsedimentation
Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5350
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| GHK | Centrifuge, Microsedimentation | 1 | 0 |
