Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6700](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6700) → GHC — Tube, Sedimentation Rate

# GHC · Tube, Sedimentation Rate

_Hematology · 21 CFR 864.6700 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHC

## Overview

- **Product Code:** GHC
- **Device Name:** Tube, Sedimentation Rate
- **Regulation:** [21 CFR 864.6700](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6700)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

## 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 (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K885114](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHC/K885114.md) | SALMONELLA IFA* | Investigacion Farmaceutica S.A. DE C.V. | Aug 15, 1989 | SESE |

## Top Applicants

- Investigacion Farmaceutica S.A. DE C.V. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHC](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GHC)

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