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 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700) → GHR — Reagent, Platelet Aggregation

# GHR · Reagent, Platelet Aggregation

_Hematology · 21 CFR 864.5700 · Class 2_

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

## Overview

- **Product Code:** GHR
- **Device Name:** Reagent, Platelet Aggregation
- **Regulation:** [21 CFR 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K061991](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K061991.md) | PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA | Helena Laboratories | Feb 23, 2007 | SESE |
| [K952252](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K952252.md) | ADP REAGENT, MODIFIED | Helena Laboratories | Sep 8, 1995 | SESE |
| [K922800](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K922800.md) | PLATELET AGGREGATION REAGENTS | Chrono-Log Corp. | Aug 26, 1992 | SESE |
| [K910800](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K910800.md) | ADP REAGENT | Helena Laboratories | May 20, 1991 | SESE |
| [K910706](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K910706.md) | COLLAGEN REAGENT CAT. NO. 5368 | Helena Laboratories | May 20, 1991 | SESE |
| [K910680](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K910680.md) | EPINEPHRINE REAGENT, CAT. NO. 5367 | Helena Laboratories | May 20, 1991 | SESE |
| [K910286](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K910286.md) | PLATELET AGGREGATION REAGENTS | Medical Diagnostic Technologies, Inc. | Mar 19, 1991 | SESE |
| [K900792](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K900792.md) | RISTOCETIN | Medical Diagnostic Technologies, Inc. | Mar 27, 1990 | SESE |
| [K832428](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K832428.md) | PLATELET AGGREGATION REAGENT SET | Helena Laboratories | Oct 20, 1983 | SESE |
| [K820422](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K820422.md) | PLATELET AGGREGOMETERS | Chrono-Log Corp. | Mar 16, 1982 | SESE |
| [K760198](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K760198.md) | KIT, PLATELET AGGREGATION REAGENT (#390) | Chrono-Log Corp. | Jul 19, 1976 | SESE |

## Top Applicants

- Helena Laboratories — 6 clearances
- Chrono-Log Corp. — 3 clearances
- Medical Diagnostic Technologies, Inc. — 2 clearances

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

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