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) → JPH — Test, Erythrocyte Sedimentation Rate

# JPH · Test, Erythrocyte Sedimentation Rate

_Hematology · 21 CFR 864.6700 · Class 1_

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

## Overview

- **Product Code:** JPH
- **Device Name:** Test, Erythrocyte 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 (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K871076](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K871076.md) | WINPETTE | Ulster Scientific, Inc. | Mar 23, 1987 | SESE |
| [K860899](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K860899.md) | DISPETTE II | Ulster Scientific, Inc. | Apr 14, 1986 | SESE |
| [K852554](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K852554.md) | SRT-SYSTEM | Microwave Development, Inc. | Jul 18, 1985 | SESE |
| [K840500](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K840500.md) | SEDIPLAST | Precision Technology, Inc. | Feb 21, 1984 | SESE |
| [K831195](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K831195.md) | WESTERGREN DISPETTE FOR ESR | Ulster Scientific, Inc. | May 9, 1983 | SESE |
| [K823761](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K823761.md) | ERYTHROCYTE & STAND SEDIMENT. RATE TUBE | Cordis Corp. | Jan 21, 1983 | SESE |
| [K823368](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JPH/K823368.md) | DADE ESR KIT | American Dade | Dec 28, 1982 | SESE |

## Top Applicants

- Ulster Scientific, Inc. — 3 clearances
- American Dade — 1 clearance
- Cordis Corp. — 1 clearance
- Microwave Development, Inc. — 1 clearance
- Precision Technology, Inc. — 1 clearance

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

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