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 864.5800](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5800) → GKB — Device, Automated Sedimentation Rate

# GKB · Device, Automated Sedimentation Rate

_Hematology · 21 CFR 864.5800 · Class 1_

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

## Overview

- **Product Code:** GKB
- **Device Name:** Device, Automated Sedimentation Rate
- **Regulation:** [21 CFR 864.5800](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5800)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K892522](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB/K892522.md) | SR30/SR50/SR60 AUTO SEDIMENT RATE SYSTEM, MODIFIED | Gespac, Inc. | May 24, 1989 | SESE |
| [K890503](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKB/K890503.md) | SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE | Gespac, Inc. | Feb 10, 1989 | SESE |

## Top Applicants

- Gespac, Inc. — 2 clearances

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

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