Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5350](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5350) → GHK — Centrifuge, Microsedimentation

# GHK · Centrifuge, Microsedimentation

_Hematology · 21 CFR 864.5350 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHK

## Overview

- **Product Code:** GHK
- **Device Name:** Centrifuge, Microsedimentation
- **Regulation:** [21 CFR 864.5350](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5350)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## 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._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHK](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHK)

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